Tuberculosis
Conditions
Interventions
The experimental arm
Sponsors
DAMIEN FOUNDATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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).
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| any grade 3-5 adverse event | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment success without relapse 12 months after the end of treatment;Ninety percent of doses of RR-TB treatment taken | — |
Countries
Niger
Contacts
Public ContactALBERTO PIUBELLO
Medical Advisor
Outcome results
None listed