Trial Outcomes & Findings for Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections. (NCT NCT00555061)

NCT ID: NCT00555061

Last Updated: 2016-12-28

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day
• Results posted on: 2016-12-28

Participant Flow

Participant milestones

Measure	Retapamulin Ointment, 1% Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Overall Study STARTED	87
Overall Study COMPLETED	78
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	Retapamulin Ointment, 1% Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Overall Study Adverse Event	3
Overall Study Protocol Violation	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2
Overall Study Participant enrolled, but never treated	1

Baseline Characteristics

Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.

Baseline characteristics by cohort

Measure	Retapamulin Ointment, 1% n=86 Participants Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Age, Continuous	10.6 months STANDARD_DEVIATION 6.89 • n=5 Participants
Gender Female	32 Participants n=5 Participants
Gender Male	54 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	46 participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	36 participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 participants n=5 Participants
Race/Ethnicity, Customized Central/South Asian	1 participants n=5 Participants
Race/Ethnicity, Customized East Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Missing	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Days 3 to 4; 4 to 8 hours post-dose of the first dose of the day

Population: 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.

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.

Outcome measures

Measure	Retapamulin Ointment, 1% n=79 Participants Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Number of Participants With Measurable Plasma Concentrations, by Age Group All ages	36 participants
Number of Participants With Measurable Plasma Concentrations, by Age Group ≥2 months to ≤6 months	17 participants
Number of Participants With Measurable Plasma Concentrations, by Age Group >6 months to ≤12 months	10 participants
Number of Participants With Measurable Plasma Concentrations, by Age Group >12 months to ≤24 months	9 participants

SECONDARY outcome

Timeframe: Follow-up, Days 12 to 16

Population: 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

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.

Outcome measures

Measure	Retapamulin Ointment, 1% n=86 Participants Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age SITL, >12 months to ≤24 months, n=6	6 participants
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age 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 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 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 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 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 SID, >12 months to ≤24 months, n=4	4 participants
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age SITL, ≥2 months to ≤6 months, n=1	1 participants
Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age SITL, >6 months to ≤12 months, n=2	2 participants

SECONDARY outcome

Timeframe: Follow-up, Days 12 to 16

Population: 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.

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.

Outcome measures

Measure	Retapamulin Ointment, 1% n=61 Participants Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Bacteriological Success Rate at Follow-up, by Baseline Pathogen All pathogens, n=93	79 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Staphylococcus aureus (SA), n=44	40 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Methicillin-resistant SA, n=3	3 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Methicillin-susceptible SA, n=41	37 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Mupirocin-susceptible SA, n=44	40 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Fuscidic acid-resistant SA, n=2	2 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Fuscidic acid-susceptible SA, n=42	38 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Streptococcus pyogenes, n=9	9 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Other Gram (+) pathogens, n=11	9 number of pathogens eradicated
Bacteriological Success Rate at Follow-up, by Baseline Pathogen Gram (-) pathogens, n=29	21 number of pathogens eradicated

SECONDARY outcome

Timeframe: Follow-up, Days 12 to 16

Population: 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.

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.

Outcome measures

Measure	Retapamulin Ointment, 1% n=61 Participants Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Number of Participants by Age With Therapeutic Response of Success All ages	51 participants
Number of Participants by Age With Therapeutic Response of Success >2 months to <=6 months, n=21	15 participants
Number of Participants by Age With Therapeutic Response of Success >6 months to <=12 months, n=20	17 participants
Number of Participants by Age With Therapeutic Response of Success >12 months to <=24 months, n=20	19 participants

Adverse Events

Retapamulin Ointment, 1%

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	Retapamulin Ointment, 1% Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Respiratory, thoracic and mediastinal disorders Cough	1.2% 1/86

Other adverse events

Measure	Retapamulin Ointment, 1% Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
Gastrointestinal disorders Diarrhea	2.3% 2/86
Skin and subcutaneous tissue disorders Atopic dermatitis	2.3% 2/86
Infections and infestations Influenza	2.3% 2/86
Gastrointestinal disorders Abdominal pain	1.2% 1/86
Gastrointestinal disorders Vomiting	1.2% 1/86
Skin and subcutaneous tissue disorders Dermatitis	1.2% 1/86
Infections and infestations Impetigo	1.2% 1/86
Skin and subcutaneous tissue disorders Skin fissure	1.2% 1/86
Immune system disorders Hypersensitivity	1.2% 1/86
Infections and infestations Pharyngitis	1.2% 1/86
Blood and lymphatic system disorders Hypochromic anemia	1.2% 1/86

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER