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Retpamulin, 1% · 1 trial · 1 indication
Follow-up is defined as 7-9 days post-therapy: Day 12-14 for retapamulin; Day 17-19 for linezolid. Clinical success at follow-up was defined as the resolution of clinically meaningful signs and symptoms of infection recorded at baseline, including a pus/exudate skin infection rating scale (SIRS) score of "0." The SIRS is used by the investigator to evaluate infected lesions. Scores on the SIRS range from 0 (absent) to 6 (severe).
| Arm | Type | Description |
|---|---|---|
| Retapamulin | EXPERIMENTAL | - |
| Linezolid | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Retpamulin Ointment, 1% | DRUG | Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days. |
| Linezolid | DRUG | Adult and adolescent (=\>12 years of age) subjects will receive one 600mg linezolid tablet (overencapsulated), or one placebo capsule, twice daily for 10 days. Pediatric subjects aged 5-11 years will receive 10mg/kg body weight of a 100mg/5mL oral linezolid suspension, or placebo suspension, twice daily for 10 days. Pediatric subjects \<5 years of age will receive 10mg/kg of a 100mg/5mL oral linezolid suspension, or placebo suspension, three times daily for 10 days. |
Inclusion Criteria: * 2 months of age or older * diagnosis of secondarily-infected traumatic lesion (SITL) or impetigo (bullous or non-bullous) * negative urine pregnancy test (females of childbearing potential) * total skin infection rating scale (SIRS) score of at least 8, which must include a pu...
Retpamulin, 1% is an investigational topical antibiotic being studied for the treatment of bacterial skin infections, including secondarily infected traumatic lesions and impetigo caused by methicillin-resistant Staphylococcus aureus (MRSA). It is applied directly to the affected skin. The drug is in Phase 3 development and has not been approved by the FDA.
Retpamulin, 1% is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 3 clinical trial evaluating the drug in patients with bacterial skin infections. The asset remains in the company's infectious disease pipeline.
Retpamulin, 1% is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for any indication.
Retpamulin, 1% has been evaluated in one completed Phase 3 trial, NCT00852540, titled Retapamulin Versus Linezolid in the Treatment of SITL and Impetigo Due to MRSA. The trial enrolled 410 participants in the United States, was randomized, double-blind, and active-controlled, and included patients as young as 2 months.
Yes, Retpamulin, 1% is also known as Retpamulin Ointment, 1%. Both names refer to the same topical small molecule antibiotic developed by GSK plc for bacterial skin infections. The ointment formulation is the one used in the completed Phase 3 trial.