RECRUITINGPhase 3INTERVENTIONAL

Novel Triple-dose Tuberculosis Retreatment Regimen

Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger

About This Trial

To determine if a high-dose first-line regimen is non-inferior (non-inferiority margin 10%) in terms of safety to the same regimen at regular dosing, in previously treated patients with rifampicin-susceptible recurrent Tuberculosis (TB).

Who May Be Eligible (Plain English)

Who May Qualify: - All newly registered patients with smear-positive recurrent pulmonary TB - Adults as well as children (no age limit) - Able and willing to provide written willing to sign a consent form - Added for stage 2: lives within 5 km of a health facility with a medical doctor Who Should NOT Join This Trial: - All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing - Patients transferred to a health facility not supported by the Damien Foundation - Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period - Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening - Pregnant or breastfeeding woman - HIV co-infected patients requiring treatment with a protease inhibitor Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * All newly registered patients with smear-positive recurrent pulmonary TB * Adults as well as children (no age limit) * Able and willing to provide written informed consent * Added for stage 2: lives within 5 km of a health facility with a medical doctor Exclusion Criteria: * All patients with TB initially resistant to rifampicin on Xpert MTB/RIF testing * Patients transferred to a health facility not supported by the Damien Foundation * Patients previously enrolled in the trial, and with another episode of rifampicin-susceptible TB during the study period * Those with grade III elevation of liver function tests at baseline, or with clinically active liver disease at screening * Pregnant or breastfeeding woman * HIV co-infected patients requiring treatment with a protease inhibitor

Treatments Being Tested

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

Locations (1)

Damien Foundation

Niamey, Niger