EBA, Safety & Tolerability of Sanfetrinem Cilexetil

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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. All treatments will be administered orally (PO) on days 1-14. The treatments are: Stage 1: - Sanfetrinem cilexetil 1.6 g PO 12-hourly - Rifampicin 35 mg/kg PO once daily (OD)* An interim analysis is planned after stage 1 to review the pharmacokinetics (PK), safety, tolerability and EBA of sanfetrinem cilexetil. Results of stage 1 will determine whether stage 2 should proceed and if any modifications in dose, duration or combinations are required for Stage 2. If deemed possible, a PK-EBA model will be derived using only stage 1 from which clinical trial simulations will be conducted to inform the design of stage 2. If EBA is not demonstrated, the study will be stopped after stage 1. Stage 2: - Rifampicin 35 mg/kg po OD* - Sanfetrinem cilexetil 3.2 g PO OD - Sanfetrinem cilexetil 800 mg PO 12-hourly - Sanfetrinem cilexetil 800 mg PO 8-hourly - Sanfetrinem cilexetil 1.6 g plus amoxicillin/clavulanic acid (Amx/CA) 250mg/125 mg, PO 12-hourly - Sanfetrinem cilexetil 1.6 g 12-hourly plus rifampicin 35 mg/kg PO OD - Five of the rifampicin 35 mg/kg arm participants will be recruited in stage 1 and the remainder in stage 2. Participants on rifampicin will serve both as control for the EBA quantitative mycobacteriology and allow evaluation of pharmacodynamic-pharmacodynamic (PD-PD) interaction between rifampicin and sanfetrinem. The study will not be blinded but the mycobacteriology laboratory staff performing the endpoint assays will remain blinded until analysis of the EBA results. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05388448
Study type	Interventional
Source	TASK Applied Science
Contact	Christelle Van Niekerk
Phone	+27211003606
Email	christelle@task.org.za
Status	Recruiting
Phase	Phase 2
Start date	April 21, 2022
Completion date	December 1, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EBA, Safety and Tolerability of Sanfetrinem Cilexetil

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms