Dose-Ranging Study of GSK2140944 in the Treatment of Subjects With Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections
Summary
GSK2140944 belongs to a novel structural class of antibiotics - Bacterial Type II Topoisomerase Inhibitors (BTI). This is a Phase II, randomized, two-part, multicenter study designed to select the optimal dose by further characterizing the safety, tolerability and PK of GSK 2140944 and by evaluating efficacy in subjects requiring in-patient medical care to treat their suspected or confirmed Gram-positive acute bacterial skin and skin structure infections (ABSSSI). The selected dose will be used in future studies.
Timeline
- Start
- 2014-03-24
- Primary completion
- 2015-06-29
- Completion
- 2015-06-29
Outcome
Mixed primary results
paper At the early efficacy visit (48 to 72 h after the first dose), the 750-mg q12h and 1,000-mg q8h groups met prespecified success criteria PMID 28373199 ↗
paper however, the 1,000-mg q12h group did not meet these criteria due to observed lower efficacy rates. PMID 28373199 ↗
Publications
- Scangarella-Oman NE, Ingraham KA, Tiffany CA, Tomsho L, Van Horn SF, Mayhew DN, Perry CR, Ashton TC, Dumont EF, Huang J, Brown JR, Miller LA. In Vitro Activity and Microbiological Efficacy of Gepotidacin from a Phase 2, Randomized, Multicenter, Dose-Ranging Study in Patients with Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2020 Feb 21;64(3):e01302-19. doi: 10.1128/AAC.01302-19. Print 2020 Feb 21.
- O'Riordan W, Tiffany C, Scangarella-Oman N, Perry C, Hossain M, Ashton T, Dumont E. Efficacy, Safety, and Tolerability of Gepotidacin (GSK2140944) in the Treatment of Patients with Suspected or Confirmed Gram-Positive Acute Bacterial Skin and Skin Structure Infections. Antimicrob Agents Chemother. 2017 May 24;61(6):e02095-16. doi: 10.1128/AAC.02095-16. Print 2017 Jun.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gepotidacin | Small molecule | 750 mg | Intravenous |
| Subject | Gepotidacin | Small molecule | 1000 mg | Intravenous |
| Subject | Gepotidacin | Small molecule | 1500 mg | Intravenous |
| Subject | Gepotidacin | Small molecule | 2000 mg | Intravenous |