NCT05388448

EBA, Safety and Tolerability of Sanfetrinem Cilexetil

A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Sanfetrinem Cilexetil Administered Orally to Adults With Newly Diagnosed, Smear-Positive, Rifampicin-Susceptible Pulmonary Tuberculosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: TASK Applied Science · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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. 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 2.4 g 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 as control for the EBA quantitative mycobacteriology. The study will not be blinded but the mycobacteriology laboratory staff performing the endpoint assays will remain blinded until analysis of the EBA results.

Conditions

• Tuberculosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Sanfetrinem Cilexetil	Sanfetrinem cilexetil powder, weighed for dose and administered as a suspension in water. Amx/CA 250/125 mg tablets Rifampicin 150 mg, 300 mg and 600 mg tablets or capsules
DRUG	Rifampicin	Rifampicin will be administered at a dose of 35 mg/kg once daily for 14 days with or without sanfetrinem cilexetil.

Timeline

• Start date: 2022-04-21
• Primary completion: 2024-08-19
• Completion: 2024-08-19
• First posted: 2022-05-24
• Last updated: 2025-02-21

Locations

1 site across 1 country: South Africa