drugset / Trial / NCT05388448
EBA, Safety and Tolerability of Sanfetrinem Cilexetil
Phase 2
Completed
54 enrolled
TASK Applied Science
European and Developing Countries Clinical Trials Partnership (EDCTP) · collabGlaxoSmithKline · collab
RandomizedSequentialOpen-labelTreatment
Summary
To evaluate the 2-week bactericidal activity, pharmacokinetics, safety and tolerability of sanfetrinem cilexetil in participants with rifampicin-susceptible pulmonary tuberculosis.
Timeline
- Start
- 2022-04-21
- Primary completion
- 2024-08-19
- Completion
- 2024-08-19
Publications
- Ramon-Garcia S, Gonzalez Del Rio R, Arenaz-Callao MP, Boshoff HI, Rullas J, Anca S, Cacho Izquierdo M, Porras de Francisco E, Perez Herran E, Santos-Villarejo A, Mendoza-Losana A, Ferrer-Bazaga S, Thompson CJ, Barros Aguirre D, Bates RH. Sanfetrinem, an oral beta-lactam antibiotic repurposed for the treatment of tuberculosis. Drug Resist Updat. 2025 May;80:101213. doi: 10.1016/j.drup.2025.101213. Epub 2025 Feb 15.
- Ramon-Garcia S, Del Rio RG, Arenaz-Callao MP, Boshoff H, Rullas J, Anca S, Izquierdo MC, de Francisco EP, Herran EP, Santos-Villarejo A, Mendoza-Losana A, Ferrer-Bazaga S, Thompson CJ, Aguirre DB, Bates RH. Sanfetrinem, an oral beta-lactam antibiotic repurposed for the treatment of tuberculosis. bioRxiv [Preprint]. 2024 Oct 10:2024.10.10.617558. doi: 10.1101/2024.10.10.617558.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rifampin | Small molecule | 35 mg/kg | Oral |
| Subject | Sanfetrinem Cilexetil | Small molecule | 1.6 g | Oral |
| Subject | Sanfetrinem Cilexetil | Small molecule | 2.4 g | Oral |