Trial · NCT02013141
Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
NCT02013141, Phase 1, Terminated, Cumberland Pharmaceuticals; results first posted 2024-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Telavancin Pediatric PK Study (Ages >12 Months to 17 Years). Trials, record NCT02013141. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02013141
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Telavancin Pediatric PK Study (Ages >12 Months to 17 Years)
- NCT number
- NCT02013141
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 22 participants, actual
- Lead sponsor
- Cumberland Pharmaceuticals
- Conditions
- Gram-Positive Bacterial Infections
- Interventions
- Telavancin
- First posted
- 2013-12-17
- Last updated
- 2024-06-24
- Results first posted
- 2024-06-24
- Limitations and caveats
Information on the pharmacokinetics and safety of a single dose of telavancin in subjects aged 2 to 5 years is limited as Cohort 3 only enrolled 1 participant due to early termination of the study. No infants were enrolled due to early termination of the study, and therefore, no information is available on the pharmacokinetics and safety of a single dose of telavancin in infants.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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. |
| Primary | Pharmacokinetics- Maximum Plasma Concentration of Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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. |
| Primary | Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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. |
| Primary | Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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. |
| Primary | Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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. |
| Secondary | Safety- Number of Treatment-emergent Adverse Events. | Day 0 (screening) through follow-up on Day 8 (+/- 1 day) | 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. |
| Secondary | Safety- Number of Subjects With Treatment-emergent Adverse Events | Day 0 (screening) through follow-up on Day 8 (+/- 1 day) | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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 | h*mcg/ml | MEAN |
| PRIMARY | Pharmacokinetics- Maximum Plasma Concentration of Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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 | mcg/mL | MEAN |
| PRIMARY | Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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 | hours | MEDIAN |
| PRIMARY | Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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 | hours | MEAN |
| PRIMARY | Pharmacokinetics- Area Under the Curve From Time Zero to the Last Sample for the Telavancin Plasma Concentration Versus Time Curve | 1.0, 1.5, 2.0, 6.0, 12.0, 24.0 hours | 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 | h*mcg/mL | MEAN |
| SECONDARY | Safety- Number of Treatment-emergent Adverse Events. | Day 0 (screening) through follow-up on Day 8 (+/- 1 day) | Safety population- includes all 22 study participants | events | NUMBER |
| SECONDARY | Safety- Number of Subjects With Treatment-emergent Adverse Events | Day 0 (screening) through follow-up on Day 8 (+/- 1 day) | Safety population- includes all 22 study participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin | Cohort 1 (Age 12 to 17 Years) | 345 | Standard Deviation 58.8 | h*mcg/ml | |
| Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin | Cohort (Age 6 to 11 Years) | 351 | Standard Deviation 79.7 | h*mcg/ml | |
| Pharmacokinetics- Area Under the Curve Extrapolated to Infinity for the Plasma Concentration Versus Time Curves for Telavancin | Cohort 3 (Age 2 to 5 Years) | 229 | Standard Deviation NA | h*mcg/ml | |
| Pharmacokinetics- Maximum Plasma Concentration of Telavancin | Cohort 1 (Age 12 to 17 Years) | 58.3 | Standard Deviation 8.40 | mcg/mL | |
| Pharmacokinetics- Maximum Plasma Concentration of Telavancin | Cohort (Age 6 to 11 Years) | 60.1 | Standard Deviation 11.9 | mcg/mL | |
| Pharmacokinetics- Maximum Plasma Concentration of Telavancin | Cohort 3 (Age 2 to 5 Years) | 53.1 | Standard Deviation NA | mcg/mL | |
| Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration | Cohort 1 (Age 12 to 17 Years) | 1.02 | Full Range 1.00 to 1.55 | hours | |
| Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration | Cohort (Age 6 to 11 Years) | 1.09 | Full Range 1.00 to 1.32 | hours | |
| Pharmacokinetics- Time to Maximum Plasma Telavancin Concentration | Cohort 3 (Age 2 to 5 Years) | 1.18 | Full Range 1.18 to 1.18 | hours | |
| Pharmacokinetics- Terminal Elimination Half-life for Plasma Telavancin | Cohort 1 (Age 12 to 17 Years) | 5.60 | Standard Deviation 1.01 | hours |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Age 12 to 17 Years) | 14 | |
| Overall Study | STARTED | Cohort 2 (Age 6 to 11 Years) | 7 | |
| Overall Study | STARTED | Cohort 3 (Age 2 to 5 Years) | 1 | |
| Overall Study | COMPLETED | Cohort 1 (Age 12 to 17 Years) | 14 | |
| Overall Study | COMPLETED | Cohort 2 (Age 6 to 11 Years) | 7 | |
| Overall Study | COMPLETED | Cohort 3 (Age 2 to 5 Years) | 1 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Age 12 to 17 Years) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Age 6 to 11 Years) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 3 (Age 2 to 5 Years) | 0 |
Source ClinicalTrials.gov
Adverse events48
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Cohort 1 (Age 12 to 17 Years) | 2 | 14 | 2 |
| other | Nausea | Gastrointestinal disorders | Cohort (Age 6 to 11 Years) | 2 | 7 | 3 |
| other | Nausea | Gastrointestinal disorders | Cohort 3 (Age 2 to 5 Years) | 0 | 1 | 0 |
| other | Vomiting | Gastrointestinal disorders | Cohort 1 (Age 12 to 17 Years) | 0 | 14 | 0 |
| other | Vomiting | Gastrointestinal disorders | Cohort (Age 6 to 11 Years) | 2 | 7 | 2 |
| other | Vomiting | Gastrointestinal disorders | Cohort 3 (Age 2 to 5 Years) | 0 | 1 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Cohort 1 (Age 12 to 17 Years) | 0 | 14 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | Cohort (Age 6 to 11 Years) | 1 | 7 | 1 |
| other | Abdominal Pain | Gastrointestinal disorders | Cohort 3 (Age 2 to 5 Years) | 0 | 1 | 0 |
| other | Abdominal discomfort | Gastrointestinal disorders | Cohort 1 (Age 12 to 17 Years) | 1 | 14 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Age 12 to 17 Years) | 0 | 14 |
| Total, all-cause mortality | Cohort (Age 6 to 11 Years) | 0 | 7 |
| Total, all-cause mortality | Cohort 3 (Age 2 to 5 Years) | 0 | 1 |
| Total, other adverse events | Cohort 1 (Age 12 to 17 Years) | 6 | 14 |
| Total, other adverse events | Cohort (Age 6 to 11 Years) | 4 | 7 |
| Total, other adverse events | Cohort 3 (Age 2 to 5 Years) | 0 | 1 |
| Total, serious adverse events | Cohort 1 (Age 12 to 17 Years) | 0 | 14 |
| Total, serious adverse events | Cohort (Age 6 to 11 Years) | 0 | 7 |
| Total, serious adverse events | Cohort 3 (Age 2 to 5 Years) | 0 | 1 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37815398 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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