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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
Phase 2 trial testing Faropenem in Pulmonary Tuberculosis in 58 participants. Completed in 2 October 2019.
28 September 2019
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 58 |
| Start date | 11 February 2019 |
| Primary completion | 28 September 2019 |
| Estimated completion | 2 October 2019 |
| Sites | 6 locations across Philippines, Singapore, Uganda |
Drugs / interventions tested
- Faropenem (FAROPENEM) — full drug profile →
- Amoxicillin/clavulanic acid
- Cefadroxil (CEFADROXIL) — full drug profile →
- Rifampicin (Rifampicin) — full drug profile →
Conditions studied
- Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →
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):
-
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02381470
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Faropenem
Trials testing the same drug.
- NCT06804096 — Efficacy and Safety of Faropenem in Bangladeshi Adult Patients With Community-Acquired Bacterial Pneumonia (CABP) · Phase 4 · recruiting
Other recruiting trials for Pulmonary Tuberculosis
Currently open trials in the same condition.
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- NCT06192160 — Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis · Phase 2 · recruiting
- NCT07186478 — I-FALMIN Albumin Supplement for Patients With Pulmonary Tuberculosis · NA · active not recruiting
- NCT06649721 — Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis:BDLL Chinese Cohort · Phase 3 · active not recruiting
- NCT06528418 — Identification of Multiple Pulmonary Diseases Using Volatile Organic Compounds Biomarkers in Human Exhaled Breath · recruiting
Other National University Hospital, Singapore trials
Trials by the same sponsor.
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- NCT07319676 — Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas · Phase 1, PHASE2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02381470 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National University Hospital, Singapore
- Last refreshed: 23 March 2020
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.
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