Tuberculosis Clinical Trial
— Tri-Do-ReOfficial title:
Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger
Verified date | February 2024 |
Source | Institute of Tropical Medicine, Belgium |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 370 |
Est. completion date | September 2025 |
Est. primary completion date | June 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Niger | Damien Foundation | Niamey |
Lead Sponsor | Collaborator |
---|---|
Institute of Tropical Medicine, Belgium | Damien Foundation |
Niger,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of patients with any grade 3-5 Adverse Event (AE) during treatment, assessed as probably or definitely related to TB treatment | 18 months | ||
Primary | Describe bacterial effectiveness specific | for stage 2 participants of the trial | 18 months | |
Primary | Describe acquired resistance specific | for stage 2 participants of the trial | 18 months | |
Secondary | number of previously treated patients with H-monoresistance and H-polyresistance, rifampicin (RMP) resistance missed by Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) | frequency of initial resistance patterns and mutations conferring resistance | 18 months | |
Secondary | Programmatical effectiveness:number of participants with treatment success divided by number of participants with failure, death, or Lost to follow-up (LTFU) | 6 months treatment success: A patient with smear-positive Pulmonary Tuberculosis (PTB) at the beginning of treatment who completed treatment and sputum smear microscopy (SSM) negative in the last month of treatment and on at least one previous occasion or culture-negative at 6 months. A patient with smear-positive PTB at the beginning of treatment who completed treatment without clinical evidence of failure but with no record of sputum smear or culture results in the last month of treatment (either because tests were not done or because results are unavailable) 18 months treatment success: Those who were cured or completed treatment and were evaluated at 12 months post-treatment to be a) SSM negative , or b) SSM positive but culture (CU) negative, or c) without sputum and no clinical signs of TB. | 6 months, 18 months | |
Secondary | Clinical effectiveness: number of participants with treatment success, divided by number of participants with failure or death | 6 months treatment success: A patient with smear-positive PTB at the beginning of treatment who completed treatment and SSM negative in the last month of treatment and on at least one previous occasion or culture-negative at 6 months. A patient with smear-positive PTB at the beginning of treatment who completed treatment without clinical evidence of failure but with no record of sputum smear or culture results in the last month of treatment (either because tests were not done or because results are unavailable) 18 months treatment success: Those who were cured or completed treatment and were evaluated at 12 months post-treatment to be a) SSM negative , or b) SSM positive but CU negative, or c) without sputum and no clinical signs of TB. | 6 months, 18 months | |
Secondary | Bacteriological effectiveness : number of participants with treatment success, divided by number of participants with failure | 6 months treatment success: A patient with smear-positive PTB at the beginning of treatment who completed treatment and SSM negative in the last month of treatment and on at least one previous occasion or culture-negative at 6 months. A patient with smear-positive PTB at the beginning of treatment who completed treatment without clinical evidence of failure but with no record of sputum smear or culture results in the last month of treatment (either because tests were not done or because results are unavailable) 18 months treatment success: Those who were cured or completed treatment and were evaluated at 12 months post-treatment to be a) SSM negative , or b) SSM positive but CU negative, or c) without sputum and no clinical signs of TB. | 6 months, 18 months | |
Secondary | number of participants with acquired resistance, to Isoniazid (INH) and/or RMP | In patients with recurrence, the recurrent strain will be compared with the diagnostic strain to identify possible differences in the resistance pattern. If the strain is the same, and resistance is not present in the diagnostic sample but is identified in the recurrence sample, then this resistance is considered as acquired. Resistance is defined as a) on genotypic Drug susceptibility testing (DST) (Deeplex or other): presence of a mutation in the resistance determining region for the drug with exception of generally recognized polymorphisms and silent mutations not leading to an error in the gene product. Heteroresistance at the proportion detectable by these methods will be considered at par with full-blown resistance, or b) growth at the critical concentration for the drug tested in phenotypic DST. | 6 months, 18 months | |
Secondary | number of participants with stable (without reversion) SSM conversion | conversion to 0 AFB per field, without subsequent treatment failure | 2 months | |
Secondary | number of participants with drug-induced hepatotoxicity | hepatotoxicity due to anti-TB drug treatment was defined as the following criteria:
Grade 3-5 elevation of Liver function test (LFT), or grade 2 elevation of liver function tests with jaundice; AND absence of serological evidence of infection with hepatitis B or C, AND normalization or at least a 50% improvement in abnormal liver chemistry results after withdrawal of anti-TB drugs |
18 months | |
Secondary | number of participants with any TB treatment change due to drug-induced hepatoxicity | 18 months | ||
Secondary | number of participants with any TB treatment change due to AE | 18 months | ||
Secondary | number of participants with any grade 3-5 AE | 18 months | ||
Secondary | number of participants with any Serious Adverse Event (SAE) | 18 months |
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