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Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB

NCT03174184 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2023-07-19

Study results available
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Summary

The overall goal of this exploratory proof-of-concept study is to determine whether, in participants with pulmonary tuberculosis caused by M. tuberculosis (MTB) with or without rifampin resistance-conferring rpoB-gene mutations, the combination of meropenem and amoxicillin/clavulanate with rifampin has greater early bactericidal activity (EBA) than the combination of meropenem and amoxicillin/clavulanate without rifampin. Funding Source- FDA OOPD.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DRUG

Rifampin

Oral administration of rifampin at a dosage of 20 mg/kg daily

DRUG

MEROPENEM 2 grams TID

Intravenous administration at a dosage of 2 grams thrice daily

DRUG

MEROPENEM 1 gram TID

Intravenous administration at a dosage of 1 gram thrice daily

DRUG

MEROPENEM 3 grams QD

Intravenous administration at a dosage of 3 grams once daily

DRUG

Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet

Amx/Clv will be administered orally at a dose of 500 mg/125 mg thrice daily

DRUG

Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet

Amx/Clv will be administered orally at a dose of 875 mg/125 mg once daily

Sponsors & Collaborators

Principal Investigators

  • Kelly Dooley, MD · Associate Professor of Medicine

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
2017-08-23
Primary Completion
2022-05-13
Completion
2022-05-13
FDA Drug
Yes

Countries

  • South Africa

Study Locations

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Entities

Drugs
Companies

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 NCT03174184 on ClinicalTrials.gov