Phase 3
N=507
Retapamulin Versus Placebo in Secondarily-Infected Traumatic Lesions (SITL)
Skin Infections, Bacterial
Bottom Line
View on ClinicalTrials.gov: NCT00684177 ↗Enrolled (actual)
507
Serious AEs
0.4%
Results posted
Aug 2010
Primary outcome: Primary: Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population — 184; 75; 62; 38 participants — p=0.098
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Retapamulin Ointment, 1% (Drug); Placebo ointment (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Primary Efficacy Population |
184; 75; 62; 38 | 0.098 |
| SECONDARY Number of Participants With Clinical Success and Failure at Follow-up (7-9 Days Post Therapy) for the Intent-to-Treat Bacteriology (ITTB) Subset of the Primary Efficacy Population |
139; 54; 43; 30 | 0.04 sig |
| SECONDARY Number of Participants With Microbiological Success and Failure at Follow-up (7-9 Days Post Therapy) |
139; 54; 43; 30 | 0.04 sig |
| SECONDARY Number of Participants With the Indicated Clinical Outcome at End of Therapy (2-4 Days Post Therapy) |
130; 52; 102; 45; 11; 14 | — |
| SECONDARY Number of Baseline Pathogens With the Indicated Microbiological Outcome at End of Therapy (2-4 Days Post Therapy) |
4; 5; 137; 49; 94; 35 | — |
| SECONDARY Number of Participants With Therapeutic Success and Failure at Follow-up (7-9 Days Post Therapy) |
139; 54; 43; 30 | — |
Summary
The purpose of Study TOC110977 is to demonstrate clinical superiority of Retapamulin ointment, 1%, over placebo in patients with secondarily-infected traumatic lesions, which includes secondarily-infected lacerations, abrasions and sutured wounds. Subjects 2 months of age and older will be treated with topical retapamulin or placebo ointment twice daily for 5 days. The primary endpoint of this study is the clinical response at follow-up (Day 12-14; 7-9 days after the end of therapy) in the intent-to-treat clinical population.
Eligibility Criteria
Inclusion criteria
- subject is aged 2 months or older
- subject has secondarily-infected traumatic lesion (laceration, sutured wound or abrasion)
- negative urine pregnancy test
- subject has total skin infection rating scale score of at least 8, including pus/exudate score of at least 3
- subject and/or parent/legal guardian is willing and able to comply with protocol
- subject or parent/legal guardian has given written informed consent or assent as applicable
Exclusion criteria
- previous hypersensitivity to pleuromutilin
- secondarily-infected animal/human bite or puncture wound
- subject has an abscess
- chronic ulcerative lesion
- underlying skin disease
- systemic signs and symptoms of infection
- infection not appropriately treated with topical antibiotic
- infection requires surgical intervention prior to or during study
- subject received systemic antibacterial or steroid, or topical therapeutic agent within 24 hours of entry into study
- serious underlying disease
- subject pregnant, breast feeding or planning a pregnancy, or unacceptable method of contraception
- other investigational drug within 30 days of study entry
- subject previously enrolled in this study
Data sourced from ClinicalTrials.gov (NCT00684177). 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.