Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
Skin Infections, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT00555061 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Retapamulin Ointment, 1% (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Measurable Plasma Concentrations, by Age Group |
36; 17; 10; 9 | — |
| SECONDARY Number of Participants With Clinical Success at Follow-up, by Type of Skin Infection and by Age |
10; 17; 17; 11; 7; 4 | — |
| SECONDARY Bacteriological Success Rate at Follow-up, by Baseline Pathogen |
79; 40; 3; 37; 40; 2 | — |
| SECONDARY Number of Participants by Age With Therapeutic Response of Success |
51; 15; 17; 19 | — |
Summary
Eligibility Criteria
Inclusion criteria
- Subject Age: The subject is ≥2 months to ≤24 months of age at study entry
- Subject Diagnosis: The subject has a diagnosis of secondarily-infected traumatic lesion (SITL), secondarily-infected dermatoses (SID), or primary impetigo (bullous or non-bullous) that is suitable for treatment with topical antibacterial therapy:
The subject has a small laceration, sutured wound or abrasion, which has a secondary bacterial infection. The infected portion of the laceration or sutured wound should not exceed 10cm in length with surrounding erythema not extending more than 2cm from the edge of the wound. Abrasions should not exceed 2% of the total body surface area with surrounding erythema not extending more than 2cm from the edge of the abrasion.
The subject has a diagnosis of inflammatory skin disease (i.e., dermatosis), such as atopic dermatitis or contact dermatitis, which has a secondary bacterial infection. The infected portion of the lesion(s) should not exceed 2% of the total body surface area.
Impetigo: The subject has a lesion or group of £10 discrete localized lesions on otherwise healthy skin, characterized by red spots or blisters without crusts which later progress to lesions which ooze and form yellow or honey-colored crusts surrounded by an erythematous margin.
- Subject SIRS Score: The subject has a total SIRS score of at least 8 (Appendix 1 Skin Infection Rating Scale)
- Protocol Compliance: The parent/legal guardian is willing to comply with the protocol
- Informed Consent: The parent/legal guardian has given written informed, dated consent for the subject to participate in the study
- French Subjects: In France, a subject will be eligible for inclusion in this study if either affiliated to or a beneficiary of a social security category
Exclusion criteria
- The subject has demonstrated a previous hypersensitivity reaction to pleuromutilin or any component of the ointment (refer to the Investigator Brochure for composition of Retapamulin ointment, 1%)
- The subject was considered to be premature at birth ( 0.125mg/kg per day of prednisone (or the equivalent)
- The subject has a known, pre-existing, serious underlying disease that could be imminently life-threatening
- The subject has participated in any study using an investigational drug during the previous 30 days prior to entering the study
- The subject has been previously enrolled in this study or in any other study involving Retapamulin
Data sourced from ClinicalTrials.gov (NCT00555061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.