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NCT02581527: RIFASHORT
A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis
Phase 3 trial testing Rifampicin in Pulmonary Tuberculosis in 672 participants. Completed in 31 July 2022.
1 January 2022
Quick facts
| Lead sponsor | St George's, University of London |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 672 |
| Start date | 1 February 2017 |
| Primary completion | 1 January 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 6 locations across Pakistan, Peru, Botswana, Guinea, Uganda, Nepal |
Drugs / interventions tested
- Rifampicin (Rifampicin) — full drug profile →
- Isoniazid (ISONIAZID) — full drug profile →
- Ethambutol (ETHAMBUTOL) — full drug profile →
- Pyrazinamide (PYRAZINAMIDE) — full drug profile →
Conditions studied
- Pulmonary Tuberculosis — all drugs for Pulmonary Tuberculosis →
Sponsor
St George's, University of London
Who can join
Adults 18 to 65, any sex, with Pulmonary Tuberculosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In this trial, the investigators are assessing whether giving an increased dose of rifampicin to patients receiving the standard treatment for tuberculosis is safe and, when given for 4 months only, will also result in greater and faster killing of the tubercle bacillus in the lungs and result in relapse rates similar to those found in the World Health Organisation (WHO) recommended standard 6 month regimen.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
New developments in tuberculosis diagnosis and treatment.
Gill CM, Dolan L, Piggott LM, McLaughlin AM. · · 2022 · cited 84× · PMID 35284018 · DOI 10.1183/20734735.0149-2021 -
Therapeutic developments for tuberculosis and nontuberculous mycobacterial lung disease.
Dartois V, Dick T. · · 2024 · cited 68× · PMID 38418662 · DOI 10.1038/s41573-024-00897-5 -
High-dose rifampicin in tuberculosis: Experiences from a Dutch tuberculosis centre.
Seijger C, Hoefsloot W, Bergsma-de Guchteneire I, Te Brake L, et al · · 2019 · cited 60× · PMID 30870476 · DOI 10.1371/journal.pone.0213718 -
The present state of the tuberculosis drug development pipeline.
J Libardo MD, Boshoff HI, Barry CE. · · 2018 · cited 58× · PMID 30144650 · DOI 10.1016/j.coph.2018.08.001 -
Preclinical Efficacy Testing of New Drug Candidates.
Nuermberger EL. · · 2017 · cited 53× · PMID 28643624 · DOI 10.1128/microbiolspec.tbtb2-0034-2017 -
Increased bactericidal activity but dose-limiting intolerability at 50 mg·kg<sup>-1</sup> rifampicin.
Te Brake LHM, de Jager V, Narunsky K, Vanker N, et al · · 2021 · cited 49× · PMID 33542056 · DOI 10.1183/13993003.00955-2020 -
Shortened treatment regimens versus the standard regimen for drug-sensitive pulmonary tuberculosis.
Grace AG, Mittal A, Jain S, Tripathy JP, et al · · 2019 · cited 45× · PMID 31828771 · DOI 10.1002/14651858.cd012918.pub2 -
Development of New Tuberculosis Drugs: Translation to Regimen Composition for Drug-Sensitive and Multidrug-Resistant Tuberculosis.
Ernest JP, Strydom N, Wang Q, Zhang N, et al · · 2021 · cited 40× · PMID 32806997 · DOI 10.1146/annurev-pharmtox-030920-011143
Verify or expand the search:
- PubMed search for NCT02581527
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Pulmonary Tuberculosis
Currently open trials in the same condition.
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- 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 St George's, University of London trials
Trials by the same sponsor.
- NCT07012421 — Community Antibiotic Use, Susceptibility and ResisTance Among Patients With Urinary Tract Infections (CAST-UTI) · recruiting
- NCT06411405 — Using Machine Learning to Model Early-onset Neonatal Sepsis Risk in Uganda and Zimbabwe · unknown
- NCT05950984 — Medical Device (MD) Derived Pharmacokinetic (PK) Parameters for Vancomycin (MD-PK) · completed
- NCT05855889 — Observational Study of the Management of Infants With Congenital CMV · recruiting
- NCT06159218 — Eosinophilic Oesophagitis Assessment With String Testing · NA · unknown
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 NCT02581527 (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 St George's, University of London
- Last refreshed: 27 April 2023
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/NCT02581527.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing