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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...
Retapamulin, 1% is a small molecule antibiotic used for the treatment of bacterial skin infections, including skin infections caused by methicillin-resistant Staphylococcus aureus (MRSA). It is being developed by GSK plc for conditions such as SITL (skin infections of traumatic lesions) and impetigo.
Retapamulin, 1% is an antibiotic that works by inhibiting bacterial protein synthesis. It is being studied for its effectiveness against bacterial skin infections, including those caused by MRSA. The drug is applied topically and is designed to treat infections at the site of application.
Retapamulin, 1% is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this drug for treating bacterial skin infections.
Retapamulin, 1% is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will help determine if the drug can be submitted for regulatory approval.
Retapamulin, 1% has one completed Phase 3 clinical trial with the identifier NCT00852540. This trial enrolled 410 participants and compared Retapamulin to linezolid in the treatment of skin infections and impetigo caused by MRSA. The trial was conducted in the United States.
Yes, Retapamulin, 1% is a formulation of the drug retapamulin. The '1%' indicates the concentration of the active ingredient in the topical formulation. Retapamulin is the active pharmaceutical ingredient, and the 1% concentration is the specific strength being studied for bacterial skin infections.