A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)
Condition(s) studied
Investigational drug(s) / intervention(s)
Isoniazid: Administered orally once daily
Rifampin: Administered orally once daily
Pyrazinamide: Administered orally once daily
Ethambutol: Administered orally once daily
Rifapentine: Administered orally once daily
Moxifloxacin: Administered orally once daily
Study 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.
Eligibility
Primary outcome measure(s)
- Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization — 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable. - Lower-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization — Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the lower-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Trial sites (29)
| Facility | City | Region | Status |
|---|---|---|---|
| Fundacion Huesped CRS (Site # 31957) | Buenos Aires | Argentina | |
| Vietnam-University of Sydney CRS (Site # 32495) | Sydney | Australia | |
| Gaborone CRS (Site #: 12701) | Gaborone | Botswana | |
| Molepolole CRS (Site # 12702) | Gaborone | Botswana | |
| Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101) | Rio de Janeiro | Brazil | |
| Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201) | Rio Grande | Brazil | |
| GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730) | Port-au-Prince | Haiti | |
| Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022) | Port-au-Prince | Haiti | |
| Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441) | Pune | Maharashtra | |
| YRG CARE CRS (Site # 32075) | Chennai | India | |
| Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601) | Eldoret | Rift Valley | |
| Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501) | Kericho | Rift Valley | |
| Malawi CRS (Site #: 12001) | Lilongwe | Central Region | |
| Blantyre CRS (Site #: 30301) | Blantyre | Malawi | |
| Nutrición-Mexico CRS (Site #: 32078) | Mexico City | Mexico | |
| Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970) | Callao | Peru | |
| Barranco CRS (Site #: 11301) | Lima | Peru | |
| San Miguel CRS (Site # 11302) | Lima | Peru | |
| Socios en Salud Sucursal Peru CRS (Site # 31985) | Lima | Peru | |
| TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981) | Dasmariñas | Cavite | |
| Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118) | Moshi | Tanzania | |
| Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802) | Pathum Wan | Bangkok | |
| Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115) | Bangkok | Thailand | |
| Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784) | Chiang Mai | Thailand | |
| Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116) | Chiang Rai | Thailand | |
| Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401) | Kampala | Uganda | |
| MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293) | Kampala | Uganda | |
| National Lung Hospital (Site #: 32483) | Hanoi | Vietnam | |
| Milton Park CRS (Site #: 30313) | Harare | Zimbabwe |
More National Institute of Allergy and Infectious Diseases (NIAID) trials in India
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07595042 on ClinicalTrials.gov ↗ ← All trials in India