High-dose treatment for recurrent tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Doxycycline added to standard treatment for central nervous system tuberculosis

  This trial tests whether adding doxycycline to standard anti‑TB therapy and corticosteroids helps adults with central nervous system tuberculosis live longer or have less severe neurological disability.

  Recruiting at 5 sites Phase 2 National University Hospital, Singapore · Medan, Medan and 5 other locations · NCT06446245

• Using Atorvastatin to treat Pulmonary Tuberculosis

  This study is testing if adding Atorvastatin, a cholesterol-lowering drug, can help people with pulmonary tuberculosis get better when they start treatment.

  Recruiting at 8 sites Phase 2 Obafemi Awolowo University Teaching Hospital · Zaria, Kaduna State and 7 other locations · NCT06199921

• Comparing the effectiveness of tedizolid and linezolid for treating tuberculosis

  This study is testing if a new drug called tedizolid can work better than an existing drug, linezolid, in helping people with tuberculosis feel better by reducing the bacteria in their lungs.

  Recruiting Phase 2 Assistance Publique - Hôpitaux de Paris · Paris · NCT05534750

• Biomarker Test for Diagnosis and Monitoring of Extrapulmonary Tuberculosis

  This study tests biomarker-based methods to help diagnose extrapulmonary TB and monitor treatment in adults, including people living with HIV, using samples from affected sites in Kenya.

  Recruiting at 2 sites Nagasaki University · Nairobi and 1 other locations · NCT07901387

• Short-Course TB Treatment for Children with Non-Severe Pulmonary TB

  This trial tests two shorter-treatment options for kids with non-severe pulmonary TB to see if they can clear the infection as well as the standard 6-month plan.

  Recruiting at 13 sites Phase 2 Huashan Hospital · Fuzhou, Fujian and 12 other locations · NCT07893444

• Channa striata and Curcuma Domestica Supplements in Active Pulmonary TB

  This study tests whether adding Channa striata extract and Curcuma domestica to standard TB care helps improve nutrition, inflammation, and quality of life in adults with active pulmonary tuberculosis.

  Recruiting at 2 sites Universitas Sumatera Utara · Medan, North Sumatera and 1 other locations · NCT07887724

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.