Trial Outcomes & Findings for Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA (NCT NCT02814916)
NCT ID: NCT02814916
Last Updated: 2024-09-19
Results Overview
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
199 participants
Primary outcome timeframe
Baseline, Day 28 (± 2 days)
Results posted on
2024-09-19
Participant Flow
Intent-to-Treat (ITT) population: all randomized participants
Participant milestones
| Measure |
Dalbavancin Single-dose
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
|---|---|---|---|
|
Overall Study
STARTED
|
91
|
78
|
30
|
|
Overall Study
COMPLETED
|
91
|
74
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
4
|
0
|
Reasons for withdrawal
| Measure |
Dalbavancin Single-dose
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
|---|---|---|---|
|
Overall Study
Withdrawal of consent
|
0
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Other, not specified
|
0
|
1
|
0
|
Baseline Characteristics
Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA
Baseline characteristics by cohort
| Measure |
Dalbavancin Single-dose
n=91 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=78 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.591 years
STANDARD_DEVIATION 5.4767 • n=5 Participants
|
8.898 years
STANDARD_DEVIATION 4.9271 • n=7 Participants
|
6.775 years
STANDARD_DEVIATION 4.2048 • n=5 Participants
|
7.980 years
STANDARD_DEVIATION 5.1270 • n=4 Participants
|
|
Age, Customized
Birth to < 3 months (Cohort 5)
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Age, Customized
3 months to < 2 years old (Cohort 4)
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Age, Customized
2 years to < 6 years old (Cohort 3)
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Age, Customized
6 years to < 12 years old (Cohort 2)
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Age, Customized
12 years to 17 years old (Cohort 1)
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
176 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (± 2 days)Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=2 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=1 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Baseline & TOC normal
|
2 Participants
|
—
|
1 Participants
|
—
|
—
|
|
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Baseline normal & TOC abnormal
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Baseline & TOC abnormal
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Distortion Product Otoacoustic Emission at TOC Visit
Baseline abnormal & TOC normal
|
0 Participants
|
—
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (± 2 days)Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=1 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Baseline normal & TOC abnormal
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Baseline & TOC normal
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Baseline abnormal & TOC normal
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Shift From Baseline in Auditory Brainstem Response Test at TOC Visit
Baseline & TOC abnormal
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (± 2 days)Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=8 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=4 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=3 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Baseline & TOC normal
|
8 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Baseline normal & TOC abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Baseline abnormal & TOC normal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Acoustic Immittance Test at TOC Visit
Baseline & TOC abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (± 2 days)Population: Participants who received at least 1 dose of study drug and had baseline and postbaseline values
Audiologic testing was to be conducted in at least 20 children \< 12 years old, of which at least 9 children were \< 2 years old. Audiologic testing conducted on infants (\< 12 months old) included: evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra and ipsilateral acoustic reflex thresholds) and (optional) threshold auditory brainstem responses. For the older children, testing included evoked otoacoustic emissions testing, acoustic immittance measures (tympanometry and contra ipsilateral acoustic reflex thresholds), and age appropriate behavioral audiologic threshold assessment. Participants with an abnormal audiologic assessment at Day 28 (± 2 days) that exceeded, by a clinically significant margin, any abnormality observed in the Baseline assessment, were considered to have an abnormal audiologic assessment.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=8 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=5 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=4 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Baseline & TOC abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Baseline & TOC normal
|
8 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Baseline abnormal & TOC normal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Behavioral Audiometric Valuation at TOC Visit
Baseline normal & TOC abnormal
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline, Day 28 (± 2 days)Population: Participants aged birth to \< 2 years who received at least 1 dose of study drug
Bowel flora was evaluated in participants from birth to \< 2 years of age by performing polymerase chain reaction (PCR) analysis for Clostridium difficile (C diff) and culture for vancomycin-resistant enterococci (VRE) on a stool specimen or rectal swab. Samples were analyzed at Baseline and at the Test of Cure (TOC) visit.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=19 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=8 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=3 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline & TOC positive
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline positive & TOC missing
|
2 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline negative & TOC positive
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline negative & TOC negative
|
10 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline negative & TOC missing
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline missing & TOC positive
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline missing & TOC negative
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline missing & TOC missing
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline & TOC positive
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline positive & TOC negative
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline positive & TOC missing
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline negative & TOC missing
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline missing & TOC positive
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline missing & TOC negative
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline missing & TOC missing
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
C diff Baseline positive & TOC negative
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline negative & TOC positive
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Shift From Baseline in Clostridium Difficile (CD) and Vancomycin-resistant Enterococci (VRE) at TOC Visit
VRE Baseline negative & TOC negative
|
15 Participants
|
5 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48-72 hoursPopulation: Participants in the mITT population with non-missing analysis values at the visit
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the modified intent-to-treat (mITT) population: all participants who received at least one dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=85 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=74 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=29 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at 48-72 Hours
Clinical Responder
|
96.5 percentage of participants
|
98.6 percentage of participants
|
89.7 percentage of participants
|
—
|
—
|
|
Clinical Response at 48-72 Hours
Clinical Non-Responder
|
3.5 percentage of participants
|
1.4 percentage of participants
|
10.3 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the mITT population with non-missing analysis values at the visit
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: For Cohorts 1-4 and Cohort 5 with ABSSSI, reduction in severity of ≥2, but not all CSSI, when compared with Baseline. For Cohort 5 with sepsis, reduction in severity of ≥1 abnormal clinical and laboratory parameter related to sepsis, when compared with Baseline. For Cohorts 1-4, no additional antibacterial Tx required for disease under study. For Cohort 5, no rescue antibiotics required after ≥48 hours of start of study Tx. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the modified intent-to-treat (mITT) population.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=84 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=73 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=29 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Clinical Cure
|
92.9 percentage of participants
|
93.2 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Clinical Failure
|
1.2 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
Improvement
|
6.0 percentage of participants
|
5.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the mITT population with non-missing analysis values at the visit
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=84 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=74 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Cure
|
90.5 percentage of participants
|
91.9 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Failure
|
2.4 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
Improvement
|
7.1 percentage of participants
|
5.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the mITT population with non-missing analysis values at the visit
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=83 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=73 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Clinical Cure
|
98.8 percentage of participants
|
98.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Clinical Failure
|
1.2 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the mITT population with non-missing analysis values at the visit
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=83 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=74 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Cure
|
95.2 percentage of participants
|
97.3 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Failure
|
2.4 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
Unknown
|
2.4 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the mITT population with non-missing analysis values at the visit
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the modified intent-to-treat (mITT) population
Outcome measures
| Measure |
Dalbavancin Single-dose
n=85 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=73 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Clinical Failure
|
1.2 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Unknown
|
1.2 percentage of participants
|
1.4 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the Follow-Up Visit (Investigator Assessment of Clinical Outcome)
Clinical Cure
|
97.6 percentage of participants
|
97.3 percentage of participants
|
100 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the mITT population with non-missing analysis values at the visit
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the modified intent-to-treat (mITT) population: all participants who received ≥1 dose of study drug and had a diagnosis of ABSSSI (or a suspected or confirmed sepsis for those in Cohort 5) not known to be caused exclusively by a Gram-negative organism.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=84 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=73 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Cure
|
96.4 percentage of participants
|
97.3 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Failure
|
2.4 percentage of participants
|
2.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response at the Follow-Up Visit (Clinical Response by Sponsor)
Unknown
|
1.2 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48-72 hoursPopulation: Participants in the microITT population with specified baseline pathogen
Clinical response defined as ≥20% reduction in lesion size compared to Baseline in Cohorts 1-4; cessation of increase in lesion size and decreased erythema or tenderness compared to Baseline with no appearance of new lesions in those with ABSSSI in Cohort 5; and improvement of at least one abnormal clinical and laboratory parameter related to sepsis in those diagnosed with sepsis in Cohort 5. To be considered a clinical responder, participants must have been alive and not have received rescue therapy. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. aureus (MRSA),Clinical Responder
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. aureus (MRSA),Clinical Non-Responder
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. aureus (MSSA),Clinical Responder
|
97.9 percentage of participants
|
95.5 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. aureus (MSSA),Clinical Non-Responder
|
2.1 percentage of participants
|
2.3 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. aureus (MSSA),Missing
|
0 percentage of participants
|
2.3 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. intermedius, Clinical Responder
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. intermedius, Clinical Non-Responder
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. pyogenes, Clinical Responder
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
E. faecalis, Clinical Responder
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
E. faecalis, Clinical Non-Responder
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. agalactiae, Clinical Responder
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. agalactiae, Clinical Non-Responder
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. anginosus, Clinical Responder
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. anginosus, Clinical Non-Responder
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. constellatus, Clinical Responder
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. constellatus, Clinical Non-Responder
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at 48-72 Hours (Clinical Response by Sponsor)
S. pyogenes, Clinical Non-Responder
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Cure: Resolution of clinical signs/symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Improvement: Cohorts 1-4 and Cohort 5 with ABSSSI: reduction in severity of ≥2, but not all CSSI, when compared to Baseline. Cohort 5 with sepsis: reduction in severity of ≥1 abnormal clinical/laboratory parameter related to sepsis, when compared to Baseline. Cohorts 1-4: no additional antibacterial Tx required for disease under study. Cohort 5: no rescue antibiotics required after ≥48 hrs of start of study Tx. Failure: Persistence/progression of Baseline CSSI after 48 hrs of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure, Improvement, or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Cure
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Improvement
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Missing
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Cure
|
91.5 percentage of participants
|
86.4 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Improvement
|
4.3 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Failure
|
2.1 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Missing
|
2.1 percentage of participants
|
6.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Improvement
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Cure
|
80 percentage of participants
|
50 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
E. faecalis, Improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
E. faecalis, Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
E. faecalis, Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Cure
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Improvement
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Failure
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Cure
|
91.5 percentage of participants
|
86.4 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Improvement
|
4.3 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Failure
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Missing
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. agalactiae, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. agalactiae, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. agalactiae, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. anginosus, Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. anginosus, Improvement
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. anginosus, Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. constellatus, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. constellatus, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. constellatus, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. intermedius, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. intermedius, Improvement
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. intermedius, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. pyogenes, Cure
|
80 percentage of participants
|
50 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. pyogenes, Improvement
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. pyogenes, Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the End of Treatment (EOT) Visit (Clinical Response by Sponsor)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Cure
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Missing
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Cure
|
95.7 percentage of participants
|
90.9 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Failure
|
2.1 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Missing
|
2.2 percentage of participants
|
6.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Cure
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Cure
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Failure
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Cure
|
91.5 percentage of participants
|
90.9 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Failure
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Unknown
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Missing
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. agalactiae, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. anginosus, Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. anginosus, Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. constellatus, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. constellatus, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. intermedius, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. intermedius, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. pyogenes, Cure
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. pyogenes, Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
E. faecalis, Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
E. faecalis, Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. agalactiae, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Test of Cure (TOC) Visit (Clinical Response by Sponsor)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the microITT population with specified baseline pathogen
Cure: Resolution of clinical signs and symptoms of infection (CSSI) compared to Baseline. No additional antibacterial Tx required for disease under study. Failure: Persistence or progression of Baseline CSSI after 48 hours of Tx OR development of new findings consistent with active infection. Unknown: Extenuating circumstances precluding classification to Cure or Failure. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Cure
|
50 percentage of participants
|
50 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Unknown
|
50 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MRSA),Missing
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Cure
|
95.7 percentage of participants
|
88.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Clinical Failure
|
2.1 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Unknown
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. aureus (MSSA),Missing
|
0 percentage of participants
|
9.1 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Cure
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Clinical Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Clinical Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Clinical Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. anginosus, Clinical Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Investigator Assessment of Clinical Outcome)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the microITT population with specified baseline pathogen
Definitions used for the Sponsor assessment were the same as those used for the Investigator assessment. The occurrence of any of the following conditions resulted in reassignment by the Sponsor to clinical failure: 1) assessment of clinical failure at a previous time point, 2) Cohorts 1-4: receipt of concomitant antibiotic with activity against participant's isolate of disease under study prior to evaluation time point; Cohort 5: receipt of rescue therapy (additional antibiotic therapy initiated ≥48 hrs after study drug start), 3) unplanned surgical procedure (e.g., incision and drainage of abscess, major debridement, amputation) for non-improving or worsening infection after 72 hrs of study drug treatment. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Cure
|
50 percentage of participants
|
50 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Failure
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Cure
|
93.6 percentage of participants
|
88.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Failure
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Unknown
|
2.1 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MSSA),Missing
|
2.1 percentage of participants
|
6.8 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. anginosus, Cure
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. anginosus, Failure
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. anginosus, Unknown
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. constellatus, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. constellatus, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. intermedius, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. intermedius, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. pyogenes, Cure
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. pyogenes, Failure
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. pyogenes, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
E. faecalis, Cure
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
E. faecalis, Failure
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
E. faecalis, Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Unknown
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. aureus (MRSA),Missing
|
50 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. agalactiae, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. agalactiae, Failure
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. agalactiae, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. constellatus, Cure
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Clinical Response by Baseline Pathogen at the Follow-up Visit (Clinical Response by Sponsor)
S. intermedius, Unknown
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48-72 hoursPopulation: Participants in the microITT population with non-missing analysis values at the visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=54 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at 48-72 Hours
Eradication
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours
Presumed eradication
|
98.1 percentage of participants
|
94.4 percentage of participants
|
88.9 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours
Persistence
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours
Presumed persistence
|
1.9 percentage of participants
|
1.9 percentage of participants
|
5.6 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours
Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
5.6 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the microITT population with non-missing analysis values at the visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=54 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the End of Treatment (EOT) Visit
Eradication
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit
Presumed persistence
|
1.9 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit
Indeterminate
|
1.9 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit
Presumed eradication
|
96.2 percentage of participants
|
92.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit
Persistence
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the microITT population with non-missing analysis values at the visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=54 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the Test of Cure (TOC) Visit
Eradication
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit
Presumed eradication
|
92.3 percentage of participants
|
92.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit
Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit
Presumed persistence
|
1.9 percentage of participants
|
3.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit
Indeterminate
|
5.8 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the microITT population with non-missing analysis values at the visit
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=54 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the Follow-Up Visit
Eradication
|
0 percentage of participants
|
1.9 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit
Presumed eradication
|
94.2 percentage of participants
|
88.9 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit
Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit
Presumed persistence
|
1.9 percentage of participants
|
3.7 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit
Indeterminate
|
3.8 percentage of participants
|
5.6 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 48-72 hoursPopulation: Participants in the microITT population with specified baseline pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical responder. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical non-responder. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing., Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Presumed persistence
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. faecalis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. faecalis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. hirae, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
G. morbillorum, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
G. morbillorum, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
L. lactis, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
L. lactis, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. anginosus, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. anginosus, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. anginosus, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. anginosus, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MRSA), Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MRSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MRSA), Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Eradication
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed eradication
|
97.9 percentage of participants
|
90.9 percentage of participants
|
85.7 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Persistence
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed persistence
|
2.1 percentage of participants
|
2.3 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
7.1 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. aureus (MSSA), Missing
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. agalactiae, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. agalactiae, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. agalactiae, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. agalactiae, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. agalactiae, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. anginosus, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. constellatus, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. constellatus, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. constellatus, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. constellatus, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. constellatus, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. intermedius, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. intermedius, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. intermedius, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. intermedius, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. intermedius, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. mitis/oralis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. mitis/oralis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. mitis/oralis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Presumed eradication
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. faecalis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. faecalis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. faecalis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. hirae, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. hirae, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. hirae, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
E. hirae, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
G. morbillorum, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
G. morbillorum, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
G. morbillorum, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
L. lactis, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
L. lactis, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at 48-72 Hours by Baseline Gram-positive Pathogen
L. lactis, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 14 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure or improvement. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed eradication
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed persistence
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Persistence
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Missing
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. intermedius, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. intermedius, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed persistence
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. faecalis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. hirae, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. faecalis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. faecalis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. hirae, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
E. hirae, Indeterminate
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Eradication
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed eradication
|
95.7 percentage of participants
|
88.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed persistence
|
2.1 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Indeterminate
|
2.1 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. anginosus, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. anginosus, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. anginosus, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. constellatus, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. constellatus, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. constellatus, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. intermedius, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed eradication
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
L. lactis, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
L. lactis, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
L. lactis, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the End of Treatment (EOT) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 28 (± 2 Days)Population: Participants in the microITT population with specified baseline pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed eradication
|
100 percentage of participants
|
75 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed eradication
|
91.5 percentage of participants
|
88.6 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed persistence
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. faecalis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. hirae, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. hirae, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Eradication
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed persistence
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Indeterminate
|
6.4 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Missing
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed persistence
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. agalactiae, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. anginosus, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. anginosus, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. anginosus, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. constellatus, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. constellatus, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. constellatus, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. intermedius, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. intermedius, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. intermedius, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed eradication
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
S. pyogenes, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. faecalis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. faecalis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. hirae, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
G. morbillorum, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
L. lactis, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
L. lactis, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Test of Cure (TOC) Visit by Baseline Gram-positive Pathogen
L. lactis, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 54 (± 7 days)Population: Participants in the microITT population with specified baseline pathogen
Eradication: Source specimen demonstrated absence of the original Baseline pathogen. Presumed eradication: Source specimen was not available to culture and the participant was assessed as a clinical cure. Persistence: Source specimen demonstrated continued presence of the original Baseline pathogen. Presumed persistence: Source specimen was not available to culture and the participant was assessed as a clinical failure. Indeterminate: Source specimen was not available to culture and the participant's clinical response was unknown or missing. Presented for the microbiological intent-to-treat (microITT) population: all randomized (or enrolled in Cohort 5) participants who had at least 1 Gram-positive pathogen isolated at Baseline.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=52 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=55 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=18 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Missing
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. agalactiae, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. agalactiae, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. anginosus, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. constellatus, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed eradication
|
80 percentage of participants
|
75 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. faecalis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. hirae, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. hirae, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
L. lactis, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
L. lactis, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Missing
|
0 percentage of participants
|
25 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Eradication
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed eradication
|
50 percentage of participants
|
50 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Presumed persistence
|
0 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MRSA), Indeterminate
|
50 percentage of participants
|
25 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Eradication
|
0 percentage of participants
|
2.3 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed eradication
|
93.6 percentage of participants
|
86.4 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Presumed persistence
|
2.1 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. aureus (MSSA), Indeterminate
|
4.3 percentage of participants
|
4.5 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed eradication
|
—
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. agalactiae, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. agalactiae, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. anginosus, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. anginosus, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. anginosus, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. constellatus, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. constellatus, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. constellatus, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. intermedius, Eradication
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. intermedius, Persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. intermedius, Presumed persistence
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. intermedius, Indeterminate
|
—
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Eradication
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. mitis/oralis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Presumed persistence
|
20 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
S. pyogenes, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. faecalis, Presumed eradication
|
100 percentage of participants
|
100 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. faecalis, Persistence
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. faecalis, Indeterminate
|
0 percentage of participants
|
0 percentage of participants
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. hirae, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
E. hirae, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
G. morbillorum, Eradication
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
G. morbillorum, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
G. morbillorum, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
G. morbillorum, Indeterminate
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed eradication
|
100 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
L. lactis, Persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Microbiological Response at the Follow-Up Visit by Baseline Gram-positive Pathogen
L. lactis, Presumed persistence
|
0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 28 (± 2 Days)Population: All participants in the ITT population
All-cause mortality was determined for the participants in Cohort 5 (birth to \< 3 months) at the Test of Cure visit.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=10 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
All-cause Mortality at the Test of Cure (TOC) Visit Among Cohort 5 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 30 min (end of infusion on Day 1); 2 hrs after start of IV (Day 1); and 48-72 hrs, 168 hrs, and 312 hrs after start of IVPopulation: All participants in the ITT population who received at least 1 dose of study drug with available data
The population pharmacokinetic (PK) profile of dalbavancin was assessed using a sparse sampling approach. Plasma PK samples were collected from participants receiving dalbavancin treatment (single-dose and two-dose arms) at 30 minutes and at 2 hours (Day 1), at 48-72 hours (Day 3-4), at 168 ± 24 hours (Day 8 ± 1), and at 312 ± 48 hours and analyzed for dalbavancin concentration.
Outcome measures
| Measure |
Dalbavancin Single-dose
n=10 Participants
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=16 Participants
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=34 Participants
Participants 3 mos to \< 6 yrs old and ≥6 yrs to 17 yrs old received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a 4000 mg total daily dose; or oxacillin 30 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs; or flucloxacillin 50 mg/kg/dose, infused over 60 (± 10) mins every 6 (± 1) hrs, not to exceed a 2000 mg total daily dose. Vancomycin was to be taken for methicillin-resistant Gram-positive infections. Based on local practice patterns/approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. At investigator's discretion, after 72 hrs of IV therapy, those on oxacillin or flucloxacillin could switch to oral cefadroxil (dose for infants/children: 15 mg/kg/dose every 12 hrs, max 2 g/day; dose for adolescents: 500-1000 mg every 12 hrs), and if infection with methicillin-resistant S. aureus was confirmed, those on vancomycin were allowed to switch to oral clindamycin 10 mg/kg every 8 hrs.
|
Participants Aged 6 Years to < 12 Years Old
n=49 Participants
Participants aged 6 years to \< 12 years old
|
12 Years to 17 Years Old (Cohort 1)
n=58 Participants
Participants aged 12 years to 17 years old
|
|---|---|---|---|---|---|
|
Concentration of Dalbavancin in Plasma
48-72 hrs after start of IV
|
53.53 µg/mL
Geometric Coefficient of Variation 24.48
|
61.32 µg/mL
Geometric Coefficient of Variation 40.08
|
56.68 µg/mL
Geometric Coefficient of Variation 46.25
|
56.93 µg/mL
Geometric Coefficient of Variation 39.79
|
60.92 µg/mL
Geometric Coefficient of Variation 28.68
|
|
Concentration of Dalbavancin in Plasma
168 hrs after start of IV
|
16.89 µg/mL
Geometric Coefficient of Variation 35.12
|
28.80 µg/mL
Geometric Coefficient of Variation 119.04
|
24.10 µg/mL
Geometric Coefficient of Variation 80.90
|
26.25 µg/mL
Geometric Coefficient of Variation 51.38
|
31.41 µg/mL
Geometric Coefficient of Variation 31.24
|
|
Concentration of Dalbavancin in Plasma
30 min (end of infusion)
|
212.43 µg/mL
Geometric Coefficient of Variation 23.32
|
268.02 µg/mL
Geometric Coefficient of Variation 44.90
|
219.45 µg/mL
Geometric Coefficient of Variation 66.72
|
211.30 µg/mL
Geometric Coefficient of Variation 34.26
|
233.58 µg/mL
Geometric Coefficient of Variation 46.44
|
|
Concentration of Dalbavancin in Plasma
2 hrs after start of IV
|
133.83 µg/mL
Geometric Coefficient of Variation 24.66
|
196.51 µg/mL
Geometric Coefficient of Variation 53.44
|
149.28 µg/mL
Geometric Coefficient of Variation 43.40
|
165.75 µg/mL
Geometric Coefficient of Variation 37.46
|
162.54 µg/mL
Geometric Coefficient of Variation 36.85
|
|
Concentration of Dalbavancin in Plasma
312 hrs after start of IV
|
4.94 µg/mL
Geometric Coefficient of Variation 47.91
|
15.24 µg/mL
Geometric Coefficient of Variation 47.97
|
12.74 µg/mL
Geometric Coefficient of Variation 45.62
|
15.35 µg/mL
Geometric Coefficient of Variation 39.40
|
20.75 µg/mL
Geometric Coefficient of Variation 37.71
|
Adverse Events
Dalbavancin Single-dose
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Dalbavancin Two-dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Comparator
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dalbavancin Single-dose
n=91 participants at risk
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=78 participants at risk
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 participants at risk
Participants 3 months to \< 6 years old and ≥6 years to 17 years old (inclusive) who were randomized to the comparator arm received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a total daily dose of 4000 mg; or oxacillin 30 mg/kg/dose or flucloxacillin 50 mg/kg/dose, not to exceed a total daily dose of 2000 mg. Based on local practice patterns and approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. Those on oxacillin or flucloxacillin were permitted to switch to oral cefadroxil (dose for infants and children: 15 mg/kg/dose every 12 hours, maximum 2 g/day; dose for adolescents: 500-1000 mg every 12 hours), and if infection with methicillin-resistant S. aureus was documented, they were allowed to switch from IV vancomycin to oral therapy with clindamycin 10 mg/kg every 8 hours at the discretion of the investigator after at least 72 hours of IV therapy.
|
|---|---|---|---|
|
Infections and infestations
ABSCESS BACTERIAL
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/78 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
Infections and infestations
OSTEOMYELITIS BACTERIAL
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/78 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
Nervous system disorders
FEBRILE CONVULSION
|
1.1%
1/91 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/78 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Dalbavancin Single-dose
n=91 participants at risk
Participants received dalbavancin administered intravenously as follows: birth to \< 3 months old and 3 months to \< 6 years old: 22.5 mg/kg (maximum 1500 mg) on Day 1; ≥6 years to 17 years old (inclusive): 18 mg/kg (maximum 1500 mg) on Day 1. Participants aged birth to \< 3 months were not randomized; all received dalbavancin single-dose.
|
Dalbavancin Two-dose
n=78 participants at risk
Participants received dalbavancin administered intravenously as follows: 3 months to \< 6 years old: 15 mg/kg (maximum 1000 mg) on Day 1, and 7.5 mg/kg (maximum 500 mg) on Day 8; ≥6 years to 17 years old (inclusive): 12 mg/kg (maximum 1000 mg) on Day 1, and 6 mg/kg (maximum 500 mg) on Day 8.
|
Comparator
n=30 participants at risk
Participants 3 months to \< 6 years old and ≥6 years to 17 years old (inclusive) who were randomized to the comparator arm received a 10-14 day course of either vancomycin 10 to 15 mg/kg/dose, not to exceed a total daily dose of 4000 mg; or oxacillin 30 mg/kg/dose or flucloxacillin 50 mg/kg/dose, not to exceed a total daily dose of 2000 mg. Based on local practice patterns and approvals for clinical use in the pediatric population, oxacillin or flucloxacillin were supplied as an IV comparator. Those on oxacillin or flucloxacillin were permitted to switch to oral cefadroxil (dose for infants and children: 15 mg/kg/dose every 12 hours, maximum 2 g/day; dose for adolescents: 500-1000 mg every 12 hours), and if infection with methicillin-resistant S. aureus was documented, they were allowed to switch from IV vancomycin to oral therapy with clindamycin 10 mg/kg every 8 hours at the discretion of the investigator after at least 72 hours of IV therapy.
|
|---|---|---|---|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
2.6%
2/78 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
General disorders
PYREXIA
|
0.00%
0/91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
2.6%
2/78 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
Infections and infestations
NASOPHARYNGITIS
|
1.1%
1/91 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/78 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.00%
0/91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
1.3%
1/78 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
3.3%
1/30 • Number of events 1 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/91 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
2.6%
2/78 • Number of events 2 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
0.00%
0/30 • All-cause mortality and adverse events were collected from the time informed consent was signed through the Final Visit. Median time on follow-up was 54.0 days for the Dalbavancin Single-dose and Dalbavancin Two-dose groups and 54.5 days for the Comparator group.
Adverse events were analyzed in the safety population which is defined as all participants in the ITT population who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER