Trial Outcomes & Findings for Telavancin Pediatric PK Study (Ages >12 Months to 17 Years) (NCT NCT02013141)
NCT ID: NCT02013141
Last Updated: 2024-06-24
Results Overview
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve extrapolated to infinity was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours
Results posted on
2024-06-24
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Age 12 to 17 Years)
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 2 (Age 6 to 11 Years)
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
7
|
1
|
|
Overall Study
COMPLETED
|
14
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
Baseline characteristics by cohort
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=14 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 2 (Age 6 to 11 Years)
n=7 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
15.1 Years
STANDARD_DEVIATION 1.69 • n=5 Participants
|
8.57 Years
STANDARD_DEVIATION 2.44 • n=7 Participants
|
2 Years
STANDARD_DEVIATION NA • n=5 Participants
|
12.4 Years
STANDARD_DEVIATION 4.27 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Ethnicity · Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
21 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
|
|
Weight
|
64.2 kg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
35.6 kg
STANDARD_DEVIATION 10.5 • n=7 Participants
|
12.3 kg
STANDARD_DEVIATION NA • n=5 Participants
|
52.9 kg
STANDARD_DEVIATION 21.4 • n=4 Participants
|
|
Height
|
165 cm
STANDARD_DEVIATION 11.9 • n=5 Participants
|
136 cm
STANDARD_DEVIATION 13.6 • n=7 Participants
|
81.0 cm
STANDARD_DEVIATION NA • n=5 Participants
|
152 cm
STANDARD_DEVIATION 24.8 • n=4 Participants
|
|
BMI
|
23.2 kg/m2
STANDARD_DEVIATION 3.63 • n=5 Participants
|
18.8 kg/m2
STANDARD_DEVIATION 2.11 • n=7 Participants
|
18.7 kg/m2
STANDARD_DEVIATION NA • n=5 Participants
|
21.6 kg/m2
STANDARD_DEVIATION 3.86 • n=4 Participants
|
PRIMARY outcome
Timeframe: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hoursPopulation: Pharmacokinetic population- one subject from Cohort 1 and one subject from Cohort 2 were excluded due to lack of pharmacokinetic plasma samples at \>1 time point
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve extrapolated to infinity was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=13 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=6 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin
|
345 h*mcg/ml
Standard Deviation 58.8
|
351 h*mcg/ml
Standard Deviation 79.7
|
229 h*mcg/ml
Standard Deviation NA
Standard deviation cannot be calculated for a single subject
|
PRIMARY outcome
Timeframe: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hoursPopulation: Pharmacokinetic population- one subject from Cohort 1 and one subject from Cohort 2 were excluded due to lack of pharmacokinetic plasma samples at \>1 time point
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=13 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=6 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Pharmacokinetics- Maximum Plasma Concentration of Telavancin
|
58.3 mcg/mL
Standard Deviation 8.40
|
60.1 mcg/mL
Standard Deviation 11.9
|
53.1 mcg/mL
Standard Deviation NA
Standard deviation cannot be calculated for a single subject
|
PRIMARY outcome
Timeframe: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hoursPopulation: Pharmacokinetic population- one subject from Cohort 1 and one subject from Cohort 2 were excluded due to lack of pharmacokinetic plasma samples at \>1 time point
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin to provide the time to maximum plasma concentration of telavancin following a single 10 mg/kg IV dose.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=13 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=6 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration
|
1.02 hours
Interval 1.0 to 1.55
|
1.09 hours
Interval 1.0 to 1.32
|
1.18 hours
Interval 1.18 to 1.18
|
PRIMARY outcome
Timeframe: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hoursPopulation: Pharmacokinetic population- one subject from Cohort 1 and one subject from Cohort 2 were excluded due to lack of pharmacokinetic plasma samples at \>1 time point
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and the terminal elimination half-life was calculated from the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=13 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=6 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin
|
5.60 hours
Standard Deviation 1.01
|
5.19 hours
Standard Deviation 0.751
|
2.73 hours
Standard Deviation NA
Standard deviation cannot be calculated for a single subject
|
PRIMARY outcome
Timeframe: 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hoursPopulation: Pharmacokinetic population- one subject from Cohort 1 and one subject from Cohort 2 were excluded due to lack of pharmacokinetic plasma samples at \>1 time point
Plasma telavancin concentrations were measured at 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours following IV infusion of telavancin, and area under the curve from time zero to the last sample was calculated for the plasma concentration versus time curves for telavancin following a single 10 mg/kg IV dose.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=13 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=6 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve
|
326 h*mcg/mL
Standard Deviation 50.0
|
333 h*mcg/mL
Standard Deviation 74.2
|
228 h*mcg/mL
Standard Deviation NA
Standard deviation cannot be calculated for a single subject
|
SECONDARY outcome
Timeframe: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)Population: Safety population- includes all 22 study participants
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=14 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=7 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Safety- Number of Treatment-emergent Adverse Events.
|
16 events
|
11 events
|
0 events
|
SECONDARY outcome
Timeframe: Day 0 (screening) through follow-up on Day 8 (+/- 1 day)Population: Safety population- includes all 22 study participants
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
Outcome measures
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=14 Participants
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=7 Participants
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 Participants
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Safety- Number of Subjects With Treatment-emergent Adverse Events
|
6 Participants
|
4 Participants
|
0 Participants
|
Adverse Events
Cohort 1 (Age 12 to 17 Years)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort (Age 6 to 11 Years)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 3 (Age 2 to 5 Years)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Age 12 to 17 Years)
n=14 participants at risk
Participants 12 to 17 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort (Age 6 to 11 Years)
n=7 participants at risk
Participants 6 to 11 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
Cohort 3 (Age 2 to 5 Years)
n=1 participants at risk
Participants 2 to 5 years of age who received 10 mg/kg IV telavancin administered over one hour one time.
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14 • Number of events 2 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
28.6%
2/7 • Number of events 3 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
28.6%
2/7 • Number of events 2 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/14 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Investigations
Lactate dehydrogenase increased
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/14 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
2/14 • Number of events 2 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Nervous system disorders
Headache
|
14.3%
2/14 • Number of events 2 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Nervous system disorders
Taste disorder
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Renal and urinary disorders
Urine abnormality
|
14.3%
2/14 • Number of events 2 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
14.3%
1/7 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Number of events 1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/7 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
0.00%
0/1 • Eight days following telavancin administration
Treatment-emergent adverse events were monitored during the study using standard measures, including physical examinations, vital signs, 12-lead ECGs, clinical laboratory assessments, urinalysis, and symptom reporting.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period up to 90 days. The sponsor can require changes to the communication but cannot extend the embargo beyond the 90 days.
- Publication restrictions are in place
Restriction type: OTHER