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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
Phase 1 trial testing Faropenem in Tuberculosis in 43 participants. Completed in 1 October 2015.
1 October 2015
Quick facts
| Lead sponsor | National University Hospital, Singapore |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 43 |
| Start date | 1 February 2015 |
| Primary completion | 1 October 2015 |
| Estimated completion | 1 October 2015 |
| Sites | 1 location across Singapore |
Drugs / interventions tested
- Faropenem (FAROPENEM) — full drug profile →
- Amoxicillin/clavulanic acid 500mg/125mg — full drug profile →
- Rifampicin (Rifampicin) — full drug profile →
Conditions studied
- Tuberculosis — all drugs for Tuberculosis →
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.
-
Cumulative WBA
Time frame: 8 hours
Cumulative bactericidal activity (WBA) reported as change in Mtb log CFU per day based on values observed (AUC)
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):
-
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:
- PubMed search for NCT02393586
- Europe PMC full search
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Related trials
Other trials of Faropenem
Trials testing the same drug.
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Other National University Hospital, Singapore trials
Trials by the same sponsor.
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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 NCT02393586 (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: 3 April 2017
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