drugset / Trial / NCT07595042
A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
Phase 2
Not yet recruiting
900 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
ViiV Healthcare · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.
Timeline
- Start
- 2026-07-31
- Primary completion
- 2029-06-05
- Completion
- 2029-10-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ethambutol | Small molecule | — | Oral |
| Subject | Moxifloxacin | Small molecule | 400 mg | Oral |
| Comparator | Rifampin | Small molecule | — | Oral |
| Subject | Rifapentine | Small molecule | 1500 mg | Oral |
| Background | Isoniazid | Small molecule | 300 mg | Oral |
| Background | Pyrazinamide | Small molecule | — | Oral |