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Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB

NCT04629378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-01-25

No results posted yet for this study

Summary

A single-center, open-label clinical trial to determine the early bactericidal activity (EBA) and safety of the combination of meropenem and amoxicillin/clavulanate plus pyrazinamide vs. meropenem and amoxicillin/clavulanate plus bedaquiline administered for 14 consecutive days. This study forms part of a series of 2-week EBA studies to determine the relative bactericidal activity of several new or repurposed anti-tuberculosis agents from which to determine the most effective and safe combination to evaluate in larger and longer duration regimen-based trials.

Conditions

Interventions

DRUG

Meropenem Injection

Meropenem IV 6 grams

DRUG

Amoxicillin Clavulanate

Amx/CA oral 1000/62.5mg 2 tablets

DRUG

Pyrazinamide

Pyrazinamide 20-30mg/kg

DRUG

Bedaquiline

Bedaquiline 400mg

DRUG

Rifafour

Rifafour (HRZE) Standard dose

Sponsors & Collaborators

  • TASK Applied Science

    lead OTHER

Principal Investigators

  • Veronique R De Jager, MBChB · TASK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2021-06-04
Completion
2021-06-04

Countries

  • South Africa

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04629378 on ClinicalTrials.gov