Novel Triple-dose Tuberculosis Retreatment Regimen

PHASE3RecruitingINTERVENTIONAL
Enrollment

370

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

September 30, 2025

Conditions
Multidrug-resistant TuberculosisPulmonary TuberculosisTuberculosisResistance to Tuberculostatic Drugs
Interventions
DRUG

6EH³R³Z

"A triple dose is defined as the triple of the routine dose used for a specific WHO weight band. Hence, the mg/kg within a weigh-band varies, as is the case in routine practice.~Dosing takings into consideration the fixed dose combination (FDC) tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E). Dosage relies on tables with dosage by weight-bands used by WHO for the Cat. 1 regimen. The dosage used for the intensive phase of the Cat. 1 regimen applies for the whole treatment duration. A double dose of H and R is added to the recommended normal dose for adults (WHO,2003)"

DRUG

6EHRZ

"Recommended normal dose adults (WHO, 2003)~* H: 5 (4-6) mg/kg/day~* R: 10 (8-12) mg/kg/day~* Z: 25 (20-30)mg/kg/day~* E: 15 (15-18)mg/kg/day"

Trial Locations (1)

Unknown

RECRUITING

Damien Foundation, Niamey

All Listed Sponsors
collaborator

Damien Foundation

OTHER

lead

Institute of Tropical Medicine, Belgium

OTHER