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Novel Triple-dose Tuberculosis Retreatment Regimen

RecruitingPhase 3Ages any - anyAllInstitute of Tropical Medicine, Belgium
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • 6EHยณRยณZ
  • 6EHRZ
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Where

1 site
Damien Foundation
Niamey, Niger
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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