Novel Triple-dose Tuberculosis Retreatment Regimen
Recruiting
Phase 3
Interventional Study
Multidrug-resistant Tuberculosis
Pulmonary Tuberculosis
Tuberculosis
Resistance to Tuberculostatic Drugs
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 370 (estimated)
- Sponsor
- Institute of Tropical Medicine, Belgium · Other
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About This Trial
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 Locations
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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:
*…
Contacts