Clinical Trial

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

Not Yet Recruiting Phase 2
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-05-12.
Trial Details
NCT Number NCT07595042
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: ViiV Healthcare
Conditions Tuberculosis
Enrollment 900 participants
Start Date 2026-07-31
Primary Completion 2029-06-05 (estimated)
Study Completion 2029-10-22 (estimated)
Updated on ClinicalTrials.gov 2026-06-15