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NCT02381470

Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers

Completed Phase 2 Last updated 23 March 2020
What this trial tests

Phase 2 trial testing Faropenem in Pulmonary Tuberculosis in 58 participants. Completed in 2 October 2019.

Timeline
11 February 2019
Primary endpoint
28 September 2019
2 October 2019

Quick facts

Lead sponsorNational University Hospital, Singapore
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment58
Start date11 February 2019
Primary completion28 September 2019
Estimated completion2 October 2019
Sites6 locations across Philippines, Singapore, Uganda

Drugs / interventions tested

Conditions studied

Sponsor

National University Hospital, Singapore

Who can join

Adults 18 to 70, any sex, with Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial aims to determine whether the early bactericidal activity of rifampicin given with faropenem or cefadroxil (each given with amoxicillin/clavulanic acid) is greater than the activity of rifampicin alone in patients with pulmonary TB. The trial will also investigate potential new biomarkers of sterilising activity.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Carbapenems to Treat Multidrug and Extensively Drug-Resistant Tuberculosis: A Systematic Review.
    Sotgiu G, D'Ambrosio L, Centis R, Tiberi S, et al · · 2016 · cited 64× · PMID 26985890 · DOI 10.3390/ijms17030373
  2. Have we realized the full potential of β-lactams for treating drug-resistant TB?
    Story-Roller E, Lamichhane G. · · 2018 · cited 35× · PMID 29934998 · DOI 10.1002/iub.1875
  3. Ethambutol and meropenem/clavulanate synergy promotes enhanced extracellular and intracellular killing of <i>Mycobacterium tuberculosis</i>.
    Olivença F, Pires D, Silveiro C, Gama B, et al · · 2024 · cited 8× · PMID 38411952 · DOI 10.1128/aac.01586-23
  4. Identification of drivers of mycobacterial resistance to peptidoglycan synthesis inhibitors.
    Olivença F, Ferreira C, Nunes A, Silveiro C, et al · · 2022 · cited 7× · PMID 36147841 · DOI 10.3389/fmicb.2022.985871
  5. Current and emerging therapies for pulmonary tuberculosis in adults.
    Mahmood A, Ashfaq MB, Drain C, Melby E, et al · · 2026 · PMID 42046646 · DOI 10.1136/bmjmed-2025-001836

Verify or expand the search:

Other trials of Faropenem

Trials testing the same drug.

Other recruiting trials for Pulmonary 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/NCT02381470.

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