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Clinical trial

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

ID
Name
ITM202001
Description
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).
Trial arms
Trial start
2021-03-01
Estimated PCD
2025-06-01
Trial end
2025-09-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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)
Arms:
6EH³R3Z
Other names:
Ethambutol; isoniazid; rifampicin; pyrazinamide, triple dose isoniazid, triple dose rifampicin
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
Arms:
6EHRZ
Other names:
Ethambutol; isoniazid; rifampicin; pyrazinamide
Size
370
Primary endpoint
number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment
18 months
Describe bacterial effectiveness specific
18 months
Describe acquired resistance specific
18 months
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Providers in the TB clinics and lab technicians in the Niger clinics and labs will not be blinded to the prescribed regimen. However, lab technicians working in the Institute of Tropical Medicine (ITM) lab will be blinded to the prescribed regimen. Also the statistician will be blinded to the prescribed regimen until the first interim analysis is completed.'}}, 'enrollmentInfo': {'count': 370, 'type': 'ESTIMATED'}}
Updated at
2024-02-15

1 organization

2 products

3 indications

Organization
Institute of Tropical Medicine
Product
6EH³R³Z
Indication
Multidrug-resistant Tuberculosis
Indication
Tuberculosis
Indication
Drug-Resistant Tuberculosis
Product
6EHRZ