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NOT YET RECRUITING
NCT07595042
PHASE2

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

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Official title: A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2026-10-30

Completion Date

2029-10-22

Last Updated

2026-08-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

Isoniazid

Administered orally once daily

DRUG

Rifampin

Administered orally once daily

DRUG

Pyrazinamide

Administered orally once daily

DRUG

Ethambutol

Administered orally once daily

DRUG

Rifapentine

Administered orally once daily

DRUG

Moxifloxacin

Administered orally once daily

Locations (29)

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, India

YRG CARE CRS (Site # 32075)

Chennai, India

Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)

Eldoret, Rift Valley, Kenya

Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)

Kericho, Rift Valley, Kenya

Malawi CRS (Site #: 12001)

Lilongwe, Central Region, Malawi

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, Philippines

Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)

Moshi, Tanzania

Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)

Pathum Wan, Bangkok, Thailand

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