Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
370 participants
INTERVENTIONAL
2021-03-01
2025-09-30
Brief Summary
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Detailed Description
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First we will perform a two-arm study with 6EHRZ as control arm and 6EH³R³Z as intervention arm. If at interim analysis the intervention arm is not considered to be non-inferior to the control arm, the intervention stops and enrolment will continue in a an adapted intervention arm and the control arm (6EHRZ). Otherwise, enrolment continues to 6EHRZ and 6EH³R³Z.
Observational study (stage 2): The DSMB members agreed due to safety concerns to continuing the study as a cohort with only the control arm. The control regimen will remain the same (6EHRZ).
As per routine practice, during treatment patients are in daily contact with the direct observed therapy (DOT) supervisor and minimally monthly clinic visits are scheduled for monitoring of safety and treatment response.
Additionally, liver function tests will be performed at fixed intervals during treatment. Six month and one year after treatment completion or cure the patient will be checked for relapse with systematic sputum acid-fast bacilli (AFB)-microscopy and TB culture.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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6EH³R3Z
(Rifampicin (R)/ Isoniazid (H) / Pyrazinamide (Z)/Ethambutol (E)) 6-month high-dose treatment; New high-dose isoniazid / high-dose rifampicin retreatment regimen (6EH³R3Z) - that includes triple-dose rifampicin (R3; 30 mg/kg), and triple-dose isoniazid (H3; 15 mg/kg), complemented with pyrazinamide (Z) and ethambutol (E).
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)
6EHRZ
Standard of care: 6-month 6RHZE regimen with dose combination tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E)
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
Interventions
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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)
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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Damien Foundation
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Sani Kadri
Role: PRINCIPAL_INVESTIGATOR
Ministry of Health, Niger
Locations
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Damien Foundation
Niamey, , Niger
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ITM202001
Identifier Type: -
Identifier Source: org_study_id
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