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NCT02581527: RIFASHORT

A Randomised Trial to Evaluate Toxicity and Efficacy of 1200mg and 1800mg Rifampicin for Pulmonary Tuberculosis

Completed Phase 3 Last updated 27 April 2023
What this trial tests

Phase 3 trial testing Rifampicin in Pulmonary Tuberculosis in 672 participants. Completed in 31 July 2022.

Timeline
1 February 2017
Primary endpoint
1 January 2022
31 July 2022

Quick facts

Lead sponsorSt George's, University of London
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment672
Start date1 February 2017
Primary completion1 January 2022
Estimated completion31 July 2022
Sites6 locations across Pakistan, Peru, Botswana, Guinea, Uganda, Nepal

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. Preclinical Efficacy Testing of New Drug Candidates.
    Nuermberger EL. · · 2017 · cited 53× · PMID 28643624 · DOI 10.1128/microbiolspec.tbtb2-0034-2017
  6. 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
  7. 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
  8. 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:

Other trials of Rifampicin

Trials testing the same drug.

Other recruiting trials for Pulmonary Tuberculosis

Currently open trials in the same condition.

Other St George's, University of London trials

Trials by the same sponsor.

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Data sources for this page

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