Active, Not Recruiting
A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
Treatment Category
Study Description
To find out whether tuberculosis (TB) can be treated safely within a shorter time using newer medicines and whether the new treatment works as well as, or better than, the standard 6-month TB treatment, and to look at whether these treatments are safe and effective for adolescents.
Study Purpose
To see if two newer TB medicines, rifapentine and moxifloxacin, allow TB to be treated safely in a shorter time.
Target Participant
- Adults and children aged 13 years or older, with or without HIV
- TB infection of the lungs confirmed by a recent laboratory test
- A reliable home address or place of residence so that treatment can be directly observed
Study Details
Assignment to treatment groups is done by chance, like flipping a coin (neither you nor the study doctor chooses the group). About 900 participants will take part in this study. Treatment length will depend on how severe the TB is and whether a longer course may be needed.
Treatments Or Drugs Involved With Study
Either:
- A treatment that includes the newer TB medicines (rifapentine and moxifloxacin)
- The current standard TB treatment
Duration Of Study
About 72 weeks (about 1 year and 4 months)
- 10 to 26 weeks of treatment
- 46 to 62 weeks of follow-up visits to monitor health and ensure TB does not return