Trial · NCT00555061
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
NCT00555061, Phase 4, Completed, GlaxoSmithKline; results first posted 2010-04-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. Trials, record NCT00555061. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00555061
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
- NCT number
- NCT00555061
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 60 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Skin Infections, Bacterial
- Interventions
- Retapamulin Ointment, 1%
- First posted
- 2007-11-07
- Last updated
- 2016-12-28
- Results first posted
- 2010-04-30
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Measurable Plasma Concentrations, by Age Group | Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day | Pharmacokinetic (PK) samples were collected randomly in the window of 4 to 8 hours post-dose (except one at 3 hours and one at 11 hours post-dose) after the first daily dose of treatment on Day 3 or Day 4. The lower limit of quantification (LLQ) for retapamulin was 0.5 ng/mL. |
| Secondary | Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Follow-up, Days 12 to 16 | SID = Secondarily Infected Dermatoses; SITL = Secondarily Infected Traumatic Lesions. Clinical Success is the number of participants with resolution of signs/symptoms of infection or improvement such that no additional antibiotic therapy was needed. |
| Secondary | Bacteriological Success Rate at Follow-up, by Baseline Pathogen | Follow-up, Days 12 to 16 | Bacteriological success is defined as: (1) Bacteriological Eradication, elimination of the baseline pathogen via culture results; (2) Presumed Bacteriological Eradication, clinical success plus no culturable material from the wound; or (3) Colonization, new pathogen identified at Follow-up in a non-symptomatic participant who does not require additional antibiotic therapy. The number of pathogens eradicated out of the number isolated (shown as "n" in the category title) for each respective category is shown. |
| Secondary | Number of Participants by Age With Therapeutic Response of Success | Follow-up, Days 12 to 16 | Therapeutic response is a measure of the overall efficacy response; a response of "therapeutic success" was based on both clinical success and bacteriological success in a given participant. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Measurable Plasma Concentrations, by Age Group | Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day | Pharmacokinetic (PK) Population: all participants who received at least one dose of study medication and who had PK samples taken. Seven participants did not have PK samples collected. | participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Follow-up, Days 12 to 16 | Intent-to-Treat Clinical (ITTC) Population: all participants who received at least one dose of study medication; the number of participants who were clinical successes out of the total number in each respective category is shown | participants | NUMBER |
| SECONDARY | Bacteriological Success Rate at Follow-up, by Baseline Pathogen | Follow-up, Days 12 to 16 | ITTB (Intent-to-Treat Bacteriological) Population: participants who had at least one dose of study medication and a clinical diagnosis of infection plus a pathogen isolated at Baseline. Participants with more than one pathogen may be represented in the table more than once. | number of pathogens eradicated | NUMBER |
| SECONDARY | Number of Participants by Age With Therapeutic Response of Success | Follow-up, Days 12 to 16 | ITTB and ITTC Populations. The number analyzed is the number of participants who were clinical successes both in the ITTC Population and the ITTB Population; the number of participants who were therapeutic successes out of the total number in each respective category is shown. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Measurable Plasma Concentrations, by Age Group | Retapamulin Ointment, 1% | All ages | 36 | participants | |
| Number of Participants With Measurable Plasma Concentrations, by Age Group | Retapamulin Ointment, 1% | ≥2 months to ≤6 months | 17 | participants | |
| Number of Participants With Measurable Plasma Concentrations, by Age Group | Retapamulin Ointment, 1% | >6 months to ≤12 months | 10 | participants | |
| Number of Participants With Measurable Plasma Concentrations, by Age Group | Retapamulin Ointment, 1% | >12 months to ≤24 months | 9 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | Impetigo, ≥2 months to ≤6 months, n=11 | 10 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | Impetigo, >6 months to ≤12 months, n=18 | 17 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | Impetigo, >12 months to ≤24 months, n=18 | 17 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | SID, ≥2 months to ≤6 months, n=17 | 11 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | SID, >6 months to ≤12 months, n=9 | 7 | participants | |
| Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age | Retapamulin Ointment, 1% | SID, >12 months to ≤24 months, n=4 | 4 | participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Retapamulin Ointment, 1% | 87 | |
| Overall Study | COMPLETED | Retapamulin Ointment, 1% | 78 | |
| Overall Study | NOT COMPLETED | Retapamulin Ointment, 1% | 9 |
Source ClinicalTrials.gov
Adverse events12
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 | Diarrhea | Gastrointestinal disorders | Retapamulin Ointment, 1% | 2 | 86 | |
| other | Atopic dermatitis | Skin and subcutaneous tissue disorders | Retapamulin Ointment, 1% | 2 | 86 | |
| other | Influenza | Infections and infestations | Retapamulin Ointment, 1% | 2 | 86 | |
| other | Abdominal pain | Gastrointestinal disorders | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Vomiting | Gastrointestinal disorders | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Dermatitis | Skin and subcutaneous tissue disorders | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Impetigo | Infections and infestations | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Skin fissure | Skin and subcutaneous tissue disorders | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Hypersensitivity | Immune system disorders | Retapamulin Ointment, 1% | 1 | 86 | |
| other | Pharyngitis | Infections and infestations | Retapamulin Ointment, 1% | 1 | 86 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Retapamulin Ointment, 1% | ||
| Total, other adverse events | Retapamulin Ointment, 1% | 11 | |
| Total, serious adverse events | Retapamulin Ointment, 1% | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00555061
GET https://conductscience.org/api/trials/v1/NCT00555061/results?page=2