CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
Rifampin +5 moredrug
Likely dose
Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03174184
NCT03174184Phase 2Completed
CompareCT.gov

A Phase 2a Study of the Early Bactericidal Activity of Rifampin (RIF) in Combination With Meropenem Plus Amoxicillin/Clavulanate Among Adults With Rifampin-resistant or Rifampin-susceptible Pulmonary Tuberculosis

Johns Hopkins University·interventional·Posted Jun 2, 2017·Updated Jul 19, 2023

In Brief

A Phase 2 clinical trial evaluating Rifampin, MEROPENEM 2 grams TID, and 4 other interventions for Tuberculosis, Pulmonary. Completed, enrolled 112 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Pulmonary
CountriesSouth Africa
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJun 2, 2017
Enrollment StartAug 23, 2017
Primary CompletionMay 13, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.1 years ago

Interventions

Rifampindrug

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

MEROPENEM 2 grams TIDdrug

Intravenous administration at a dosage of 2 grams thrice daily

MEROPENEM 1 gram TIDdrug

Intravenous administration at a dosage of 1 gram thrice daily

MEROPENEM 3 grams QDdrug

Intravenous administration at a dosage of 3 grams once daily

Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tabletdrug

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

Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tabletdrug

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