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 Rifampin Small molecule Oral
Subject Rifapentine Small molecule 1500 mg Oral
Background Isoniazid Small molecule 300 mg Oral
Background Pyrazinamide Small molecule Oral

Indications