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NCT02393586

Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers

Completed Phase 1 Last updated 3 April 2017
What this trial tests

Phase 1 trial testing Faropenem in Tuberculosis in 43 participants. Completed in 1 October 2015.

Timeline
1 February 2015
Primary endpoint
1 October 2015
1 October 2015

Quick facts

Lead sponsorNational University Hospital, Singapore
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment43
Start date1 February 2015
Primary completion1 October 2015
Estimated completion1 October 2015
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

National University Hospital, Singapore

Who can join

21 and older, any sex, with Tuberculosis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The purpose of this study is to evaluate the bactericidal activity against Mycobacterium tuberculosis of faropenem boosted with amoxicillin/clavulanic acid. Pharmacokinetics (PK) and Whole blood Bactericidal Activity (WBA) will be measured in healthy volunteers following single doses of faropenem plus amoxicillin/clavulanic acid.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Activity of faropenem with and without rifampicin against Mycobacterium tuberculosis: evaluation in a whole-blood bactericidal activity trial.
    Gurumurthy M, Verma R, Naftalin CM, Hee KH, et al · · 2017 · cited 15× · PMID 28333342 · DOI 10.1093/jac/dkx081

Verify or expand the search:

Other trials of Faropenem

Trials testing the same drug.

Other recruiting trials for Tuberculosis

Currently open trials in the same condition.

Other National University Hospital, Singapore trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02393586.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing