Last reviewed · How we verify
NCT02349841
A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem, Administered Intravenously, Plus Amoxycillin/CA and Faropenem, Administered Orally, Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed, Smear-positive Pulmonary Tuberculosis.
Phase 2 trial testing Meropenem in Pulmonary Tuberculosis in 46 participants. Completed in 1 December 2014.
1 December 2014
Quick facts
| Lead sponsor | TASK Applied Science |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 September 2014 |
| Primary completion | 1 December 2014 |
| Estimated completion | 1 December 2014 |
| Sites | 1 location across South Africa |
Drugs / interventions tested
- Meropenem (Meropenem) — full drug profile →
- Faropenem (FAROPENEM) — full drug profile →
- Amoxycillin/clavulanic acid — full drug profile →
- Rifafour e275 — full drug profile →
Conditions studied
- Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →
Sponsor
TASK Applied Science — full company profile →
Who can join
Adults 18 to 65, any sex, with Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Primary Endpoint (The EBA CFU(0-14) as determined by the rate of change in logCFU per ml sputum)
Time frame: 14 days
The EBA CFU(0-14) as determined by the rate of change in logCFU per ml sputum over the period Day 0 to Day 14 which will be described with at most 3 parameters from a linear, bi-linear or non-linear regression of logCFU on time
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Treatment of Drug-Resistant Tuberculosis. An Official ATS/CDC/ERS/IDSA Clinical Practice Guideline.
Nahid P, Mase SR, Migliori GB, Sotgiu G, et al · · 2019 · cited 301× · PMID 31729908 · DOI 10.1164/rccm.201909-1874st -
Antibiotics in the clinical pipeline as of December 2022.
Butler MS, Henderson IR, Capon RJ, Blaskovich MAT. · · 2023 · cited 147× · PMID 37291465 · DOI 10.1038/s41429-023-00629-8 -
Non-classical transpeptidases yield insight into new antibacterials.
Kumar P, Kumar P, Kaushik A, Lloyd EP, et al · · 2017 · cited 128× · PMID 27820797 · DOI 10.1038/nchembio.2237 -
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 -
Combinations of β-Lactam Antibiotics Currently in Clinical Trials Are Efficacious in a DHP-I-Deficient Mouse Model of Tuberculosis Infection.
Rullas J, Dhar N, McKinney JD, García-Pérez A, et al · · 2015 · cited 33× · PMID 25987618 · DOI 10.1128/aac.01063-15 -
Hydrolysis of clavulanate by Mycobacterium tuberculosis β-lactamase BlaC harboring a canonical SDN motif.
Soroka D, Li de la Sierra-Gallay I, Dubée V, Triboulet S, et al · · 2015 · cited 30× · PMID 26149997 · DOI 10.1128/aac.00598-15 -
Susceptibility Testing of Antibiotics That Degrade Faster than the Doubling Time of Slow-Growing Mycobacteria: Ertapenem Sterilizing Effect versus Mycobacterium tuberculosis.
Srivastava S, van Rijn SP, Wessels AM, Alffenaar JW, et al · · 2016 · cited 26× · PMID 26926650 · DOI 10.1128/aac.02924-15
Verify or expand the search:
- PubMed search for NCT02349841
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Meropenem
Trials testing the same drug.
- NCT06184659 — Empirical Meropenem Versus Piperacillin/Tazobactam for Adult Patients With Sepsis · Phase 4 · recruiting
- NCT07445282 — This Randomized Controlled Trial Evaluates the Comparative Efficacy of Intravenous Meropenem Alone Versus Intravenous Me · Phase 4 · completed
- NCT06916156 — Evaluation of the Concentration of ANT3310 and Meropenem in the Lung in Healthy Adult Participants · Phase 1 · completed
- NCT06527677 — Assessment of the Pharmacokinetics and Safety of ANT3310 Combined With Meropenem in Renally Impaired Subjects · Phase 1 · completed
- NCT05905913 — FiH Study to Assess Safety and PK of SAD and MAD of ANT3310 Alone and in Combination With Meropenem in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Pulmonary Tuberculosis
Currently open trials in the same condition.
- NCT07209761 — A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis · Phase 3 · recruiting
- 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 TASK Applied Science trials
Trials by the same sponsor.
- NCT06748937 — A Study of the Early Effects, Safety, and Acceptability of Oral Alpibectir in Combination With Ethionamide · Phase 2 · recruiting
- NCT05473195 — A Phase 2 Trial to Evaluate the EBA, Safety and Tolerability of Eto Alone and in Combination With BVL-GSK098 · Phase 2 · completed
- NCT05388448 — EBA, Safety and Tolerability of Sanfetrinem Cilexetil · Phase 2 · completed
- NCT04629378 — Evaluating the EBA of Meropenem With Amoxicillin/Clavulanate and Pyrazinamide or Bedaquiline in Adults With PTB · Phase 2 · completed
- NCT04379336 — BCG Vaccination for Healthcare Workers in COVID-19 Pandemic · Phase 3 · completed
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 NCT02349841 (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 TASK Applied Science
- Last refreshed: 11 September 2018
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/NCT02349841.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing