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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.
* Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.
* Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.
* Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.
* If living with HIV, has a CD4+ cell count of at least 50 cells/mm3 within 60 days before study entry.
* If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.
* Has laboratory test results within 7 days before study entry that meet all of the following:
* alanine aminotransferase (ALT) no more than 3 times the upper limit of normal
* total bilirubin no more than 2.5 times the upper limit of normal
* creatinine no more than 2 times the upper limit of normal
* potassium between 3.5 and 5.5 mEq/L
* absolute neutrophil count at least 1000/mm3
* hemoglobin at least 7.0 g/dL
* platelet count at least 100,000/mm3
* If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.
* If able to becom…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization
Timeframe: 52 weeks after randomization
2
Lower-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
Timeframe: Baseline through 28 weeks after randomization
Trial details
NCT IDNCT07595042
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)