drugset / Trial / NCT07595042

A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)

NCT07595042 ↗

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

EvaluationDrugModalityDoseRoute
Comparator Ethambutol Small molecule — Oral
Subject Moxifloxacin Small molecule 400 mg Oral
Comparator Rifampicin Small molecule — Oral
Subject Rifapentine Small molecule 1500 mg Oral
Background Isoniazid Small molecule 300 mg Oral
Background Pyrazinamide Small molecule — Oral

Indications