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Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem Plus Amoxycillin/CA and Faropenem Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed Pulmonary Tuberculosis

NCT02349841 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-09-13

No results posted yet for this study

Summary

To evaluate the early bactericidal activity (EBA), safety, tolerability and pharmacokinetics of meropenem administered intravenously three times a day, plus amoxycillin/CA administered orally three times a day; and of faropenem administered orally three times a day, plus amoxycillin/CA administered orally three times a day; for 14 consecutive days, in adult participants with newly diagnosed, smear positive pulmonary tuberculosis, in order to help establish proof-of-concept for carbapenem antibiotics as antituberculosis agents and to select the appropriate agent and route of administration for later stage clinical development.

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Meropenem

To administer 2g daily 8 hourly for 14 days

DRUG

Faropenem

To adminster 600mg 8 hourly daily for 14 days

DRUG

Amoxycillin/clavulanic acid

To administer 625mg 8 hourly daily for 14 days together with the faropenem and meropenem

DRUG

Rifafour e275

To be taken as per the National TB treatment programme for 14 days

Sponsors & Collaborators

  • Eduardo Mondlane University

    collaborator OTHER

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Barcelona Centre for International Health Research

    collaborator OTHER

  • Research Center Borstel

    collaborator OTHER

  • TASK Applied Science

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT02349841 on ClinicalTrials.gov