Safety, effectiveness, and feasibility of a short and all-oral treatment regimen for the treatment of rifampicin-resistant tuberculosis in Niger
- Conditions
- Tuberculosis
- Registration Number
- PACTR202203645724919
- Lead Sponsor
- DAMIEN FOUNDATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 230
1) have bacteriologically confirmed TB with evidence of resistance to rifampicin (for children the diagnosis is not always bacteriologically confirmed as the RR-TB diagnosis may be based on clinical TB diagnosis plus history of a close contact with a confirmed RR-TB case) and susceptibility to fluoroquinolones and
2) be willing and able to give informed consent to participate in the study (signed or witnessed consent if the patient is illiterate; signed or witnessed consent by a child's parent or legal guardian).
1) previous treatment for more than one month with second-line TB drugs included in the to be evaluated treatment regimens,
2) a QTcF interval = 500 msec at baseline that is not corrected by medical management,
3) any other medical contraindications for taking the study regimens,
4) being younger than 6 years old, and
5) diabetes mellitus.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method any grade 3-5 adverse event
- Secondary Outcome Measures
Name Time Method Treatment success without relapse 12 months after the end of treatment;Ninety percent of doses of RR-TB treatment taken