Trial Outcomes & Findings for Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis (NCT NCT02424734)
NCT ID: NCT02424734
Last Updated: 2018-09-13
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Baseline up to SFU visit (up to a maximum study duration of 49 days)
Results posted on
2018-09-13
Participant Flow
Participant milestones
| Measure |
Ceftaroline Fosamil: Young Infants
Young infants aged greater than (\>) 28 days to less than (\<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
Term Neonates (defined as gestational age greater than or equal to \[\>=\] 37 weeks) aged 7 to less than equal to (\<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
2
|
|
Overall Study
Treated
|
4
|
5
|
2
|
|
Overall Study
COMPLETED
|
2
|
3
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Ceftaroline Fosamil: Young Infants
Young infants aged greater than (\>) 28 days to less than (\<) 60 days, received ceftaroline fosamil infusion, intravenously (IV) at a dose of 4 milligrams per kilogram (mg/kg) or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
Term Neonates (defined as gestational age greater than or equal to \[\>=\] 37 weeks) aged 7 to less than equal to (\<=28) days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Overall Study
Treatment stopped to be discharged home
|
2
|
2
|
0
|
Baseline Characteristics
Safety, Tolerability and Efficacy of Ceftaroline in Paediatrics With Late-Onset Sepsis
Baseline characteristics by cohort
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=5 Participants
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=2 Participants
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.0 days
STANDARD_DEVIATION 4.69 • n=5 Participants
|
22.0 days
STANDARD_DEVIATION 3.81 • n=7 Participants
|
15.5 days
STANDARD_DEVIATION 4.95 • n=5 Participants
|
30.3 days
STANDARD_DEVIATION 14.78 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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 up to SFU visit (up to a maximum study duration of 49 days)Population: Safety analysis set consisted of all enrolled participants for whom informed consent form was signed and received any amount of ceftaroline fosamil.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to study follow-up (SFU) visit (28 to 35 days after last dose of study treatment) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=5 Participants
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=2 Participants
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
AEs
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
SAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Discontinuations Due to AEs
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At the end of infusion (EOI)Population: Pharmacokinetic (PK) analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above limit of quantification (LOQ). LOQ was 50 nanogram per milliliter (ng/mL).
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=11 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Plasma Concentration of Ceftaroline Fosamil
Participant 1
|
67.7 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline Fosamil
Participant 2
|
63.7 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline Fosamil
Participant 3
|
74.5 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOIPopulation: PK analysis set included all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Ceftaroline fosamil was the prodrug of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=11 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Plasma Concentration of Ceftaroline
Participant 1: 3 to 4 hrs EOI
|
3420 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 2: At EOI
|
12400 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 2: At 3 to 4 hours after EOI
|
4280 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 3: At EOI
|
7890 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 3: At 3 to 4 hours after EOI
|
1760 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 4: At 15 minutes to 2 hours after EOI
|
9440 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 4: At 5 to 7 hours after EOI
|
1800 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 5: At EOI
|
9410 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 6: 15 minutes to 2 hours after EOI
|
4370 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 7: At 15 minutes to 2 hours after EOI
|
5550 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 7: At 5 to 7 hours after EOI
|
1870 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 8:At 15 minutes to 2 hours after EOI
|
2240 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 8: At 5 to 7 hours after EOI
|
4770 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 9: At 15 minutes to 2 hours after EOI
|
4750 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 9: At 5 to 7 hours after EOI
|
1700 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 10: At EOI
|
9700 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 10: At 3 to 4 hours after EOI
|
3550 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 11: At 15 minutes to 2 hours after EOI
|
4760 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline
Participant 11: At 5 to 7 hours after EOI
|
2440 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: At EOI, 15 minutes to 2 hours, 3 to 4 hours and 5 to 7 hours after EOIPopulation: The PK analysis set will include all participants who received a known amount of ceftaroline fosamil, were randomized to a PK sample collection schedule, and had at least 1 PK sample collected.
Ceftaroline M-1 was the inactive metabolite of ceftaroline. Data was not summarized and provided for individual participants only and reported in this end point for only those participants who had concentrations above LOQ at any specific time-point. LOQ was 50 ng/mL
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=11 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Plasma Concentration of Ceftaroline M-1
Participant 1: At 3 to 4 hours after EOI
|
729 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 2: At EOI
|
678 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 2: At 3 to 4 hours after EOI
|
749 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 3: At EOI
|
950 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 3: At 3 to 4 hours after EOI
|
559 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 4: At 15 minutes to 2 hours after EOI
|
970 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 4: At 5 to 7 hours after EOI
|
642 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 5: At EOI
|
850 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 6: At 15 minutes to 2 hours after EOI
|
832 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 7: At 15 minutes to 2 hours after EOI
|
728 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 7: At 5 to 7 hours after EOI
|
634 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 8: At 15 minutes to 2 hours after EOI
|
630 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 8: At 5 to 7 hours after EOI
|
785 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 9: At 15 minutes to 2 hours after EOI
|
592 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 9: At 5 to 7 hours after EOI
|
461 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 10: At EOI
|
575 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 10: At 3 to 4 hours after EOI
|
648 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 11: At 15 minutes to 2 hours after EOI
|
671 ng/mL
|
—
|
—
|
|
Plasma Concentration of Ceftaroline M-1
Participant 11: At 5 to 7 hours after EOI
|
646 ng/mL
|
—
|
—
|
SECONDARY outcome
Timeframe: EOT visit (up to Day 15), TOC visit (up to Day 29)Population: Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment \[defined as presence of \>=2 clinical criteria, \>=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy\]).
Clinical response was assessed by the investigator as Cure, Failure or Indeterminate at End of treatment (EOT) and Test of Cure (TOC). Favorable clinical response was defined as clinical response of Cure (defined as resolution of all acute signs and symptoms of Late-onset sepsis \[LOS\] or improvement to such an extent that no further antibacterial therapy is required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after the last dose of study therapy.
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=3 Participants
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=1 Participants
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Percentage of Participants With Favorable Clinical Response
At EOT visit
|
50.0 percentage of participants
Interval 12.3 to 87.7
|
33.3 percentage of participants
Interval 3.9 to 82.3
|
100 percentage of participants
Interval 14.7 to 100.0
|
|
Percentage of Participants With Favorable Clinical Response
At TOC visit
|
50.0 percentage of participants
Interval 12.3 to 87.7
|
33.3 percentage of participants
Interval 3.9 to 82.3
|
100 percentage of participants
Interval 14.7 to 100.0
|
SECONDARY outcome
Timeframe: EOT visit (up to Day 15), TOC visit (up to Day 29)Population: Modified ITT analysis set: participants who received ceftaroline fosamil and met minimal disease criteria of late-onset sepsis (diagnosis of sepsis within 36 hours before enrolment \[defined as presence of \>=2 clinical criteria, \>=1 laboratory criteria in presence of or as a result of suspected /proven bacterial infection that requires IV therapy).
Microbiological response was determining programmatically and assessed at the participants level at EOT and TOC. Microbiological response was defined as Favorable (Eradication or Presumed Eradication), Unfavorable (Persistence or Presumed Persistence) or Indeterminate (participant's clinical response is Indeterminate and no microbiological culture data is available). Eradication defined as absence of the original baseline pathogen from the source specimen; presumed eradication was defined when source specimen was not available to culture and the participant was assessed as a clinical cure (resolution of all acute signs and symptoms of LOS or improvement to such an extent that no further antibacterial therapy was required). EOT visit occurred within 24 hours after the end of last infusion. TOC visit occurred within 8 to 15 days after last dose of study drug.
Outcome measures
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 Participants
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=3 Participants
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=1 Participants
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Percentage of Participants With Favorable Microbiological Response
At EOT visit
|
50.0 percentage of participants
Interval 12.3 to 87.7
|
66.7 percentage of participants
Interval 17.7 to 96.1
|
100 percentage of participants
Interval 14.7 to 100.0
|
|
Percentage of Participants With Favorable Microbiological Response
At TOC visit
|
25.0 percentage of participants
Interval 2.8 to 71.6
|
33.3 percentage of participants
Interval 3.9 to 82.3
|
100 percentage of participants
Interval 14.7 to 100.0
|
Adverse Events
Ceftaroline Fosamil: Young Infants
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ceftaroline Fosamil: Term Neonates
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ceftaroline Fosamil: Preterm Neonates
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 participants at risk
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=5 participants at risk
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=2 participants at risk
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Infections and infestations
Salmonellosis
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Other adverse events
| Measure |
Ceftaroline Fosamil: Young Infants
n=4 participants at risk
Young infants aged \>28 days to \<60 days, received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Term Neonates
n=5 participants at risk
Term Neonates (defined as gestational age \>= 37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
Ceftaroline Fosamil: Preterm Neonates
n=2 participants at risk
Preterm neonates (defined as gestational age \>=34 weeks to \<37 weeks) aged 7 to \<=28 days received ceftaroline fosamil infusion, IV at a dose of 4 mg/kg or 6 mg/kg over 60 minutes every 8 hours in combination with ampicillin IV as per local standard of care, for a minimum of 48 hours and up to a maximum duration of 14 days. Along with this, participants received an aminoglycoside which was optional and could be started and stopped at any time during the study at the discretion of investigator.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
1/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
1/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
1/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
20.0%
1/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Pyelocaliectasis
|
25.0%
1/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
|
Renal and urinary disorders
Rhinitis
|
0.00%
0/4 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
0.00%
0/5 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
50.0%
1/2 • Baseline up to SFU visit (up to a maximum study duration of 49 days)
Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER