High-dose treatment for recurrent tuberculosis
Novel Triple-dose Tuberculosis Retreatment Regimen: How to Overcome Resistance Without Creating More in Niger
This study is testing a higher dose of a new treatment for people with recurring tuberculosis to see if it works as well as the standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 370 (estimated) |
| Sex | All |
| Sponsor | Institute of Tropical Medicine, Belgium Academic / other |
| Locations | 1 site (Niamey) |
| Trial ID | NCT04260477 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and efficacy of a high-dose first-line regimen for treating rifampicin-susceptible recurrent tuberculosis in previously treated patients. It is a pragmatic, open-label, multi-stage randomized trial that compares a novel treatment regimen (6EH³R³Z) against a standard control regimen (6EHRZ). Participants will be monitored closely through direct observed therapy and regular clinic visits, with liver function tests conducted at set intervals. If the new regimen is found to be non-inferior in safety to the control, the trial will continue; otherwise, it will adapt to focus solely on the control regimen.
Who should consider this trial
Good fit: Ideal candidates include adults and children with smear-positive recurrent pulmonary tuberculosis who can provide informed consent and live within 5 km of a participating health facility.
Not a fit: Patients with initial rifampicin-resistant tuberculosis or those with significant liver disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a more effective treatment option for patients with recurrent tuberculosis, potentially reducing relapse rates.
How similar studies have performed: While this approach is novel, similar studies have shown promise in improving treatment outcomes for tuberculosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Niamey
- Damien Foundation — Niamey, Niger (Recruiting)
Study contacts
- Principal investigator: Sani Kadri — Ministry of Health, Niger
- Study coordinator: Natacha Herssens, MSc
- Email: nherssens@itg.be
- Phone: 003232470778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.