Phase 2: EBA, Safety and Tolerability of Sanfetrinem Cilexetil

Submitted by zaidtanvir on

Brief Summary:

To evaluate the 2-week bactericidal activity, pharmacokinetics, safety and tolerability of sanfetrinem cilexetil in participants with rifampicin-susceptible pulmonary tuberculosis.

Detailed Description:

A single-centre, open-label, clinical trial in two stages. Stage 1 will recruit 20 participants followed by a recruitment pause and an interim analysis to determine if sanfetrinem cilexetil has early bactericidal activity (EBA). Should EBA be demonstrated, stage 2 will focus on optimising sanfetrinem cilexetil.

Phase 2 EBA: bEto TB

Submitted by zaidtanvir on

This project brings a new anti-TB molecule, BVL-GSK098, to the current drug armamentarium. BVL-GSK098 greatly augments the activity of, and overcomes resistance to, the well-established second line drug ethionamide (Eto) at a lower and well-tolerated dose.

The overall aim of the project is to find a combination of BVL-GSK098 and low-lose Eto that is well tolerated, highly active and free of bacterial resistance so that the combination can be proposed to replace INH or to add a novel bactericidal drug to future TB regimens.

Objectives

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