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

Phase 3 Completed 672 enrolled St George's, University of London London School of Hygiene and Tropical Medicine · collab University of Botswana · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2017-02-01
Primary completion: 2022-01-01
Completion: 2022-07-31

Outcome

Missed primary endpoint

paper Noninferiority was not shown. PMID 38320155 ↗

paper failed to meet noninferiority criteria compared with the standard 6-month control regimen for treatment of pulmonary tuberculosis. PMID 38320155 ↗

Publications

Jindani A, Atwine D, Grint D, Bah B, Adams J, Ticona ER, Shrestha B, Agizew T, Hamid S, Jamil B, Byamukama A, Kananura K, Mugisha Taremwa I, Bonnet M, Camara LM, Bah-Sow OY, Bah KS, Bah NM, Sow M, Ticona Huaroto CE, Mugruza Pineda R, Tandukar B, Raya BB, Shrestha N, Mathoma A, Mathebula-Modongo UP, Basotli J, Irfan M, Begum D, Muzammil A, Ahmed I, Hasan R, Burgos MV, Sultan F, Hassan M, Masood I, Robb C, Decker J, Grubnic S, Butcher PD, Witney A, Dhillon J, Munshi T, Fielding K, Harrison TS. Four-Month High-Dose Rifampicin Regimens for Pulmonary Tuberculosis. NEJM Evid. 2023 Sep;2(9):EVIDoa2300054. doi: 10.1056/EVIDoa2300054. Epub 2023 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Rifampicin	Small molecule	150 mg	—
Subject	Rifampicin	Small molecule	1200 mg	—
Subject	Rifampicin	Small molecule	1800 mg	—
Background	Ethambutol	Small molecule	275 mg	—
Background	Isoniazid	Small molecule	75 mg	—
Background	Pyrazinamide	Small molecule	400 mg	—