Actively Recruiting
Novel Triple-dose Tuberculosis Retreatment Regimen
Led by Institute of Tropical Medicine, Belgium · Updated on 2025-04-13
370
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
Sponsors
I
Institute of Tropical Medicine, Belgium
Lead Sponsor
D
Damien Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Novel Triple-dose Tuberculosis Retreatment Regimen
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Lives within 5 km of a health facility with a medical doctor (added for stage 2)
You will not qualify if you...
- 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 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 women
- HIV co-infected patients requiring treatment with a protease inhibitor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Damien Foundation
Niamey, Niger
Actively Recruiting
Research Team
N
Natacha Herssens, MSc
CONTACT
T
Tom Decroo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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