Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
Recruiting now · Not applicable
Conditions studied: Tuberculosis Infection, Household Contacts, Children, Adolescent, Tuberculosis Infection, Latent, Tuberculosis
In brief
The goal of this cluster-randomized controlled trial is to evaluate the effectiveness of tuberculosis preventive treatment (TPT) administered during the "window period" to prevent new Mycobacterium tuberculosis infections in children and adolescents. The main question it aims to answer is: Can immediate TPT reduce the incidence of IGRA conversions in children and adolescents who are household contacts of a newly diagnosed pulmonary tuberculosis patient? Researchers will compare the incidence of new tuberculosis infections-measured by IGRA conversion at 12 weeks-between participants who receive immediate TPT while still uninfected (baseline IGRA-negative) and those who receive standard care, in which TPT is not offered to IGRA-negative contacts. Participants will be: 1. Tested for M. tuberculosis infection using the Interferon-Gamma Release Assay (IGRA), specifically the QuantiFERON-TB Gold Plus, at enrollment and after 12 weeks of follow-up. 2. Take weekly isoniazid and rifapentine for 12 weeks if: 1. They are assigned to the intervention arm (regardless of baseline IGRA result), or 2. They are in the control arm and test IGRA-positive at baseline. Additionally, participants from the control arm who experience an IGRA conversion at 12 weeks (following the primary outcome assessment) will also receive TPT, as per standard of care.
Key facts
- Study ID
- NCT07086820
- Run by
- Pontificia Universidad Catolica de Chile
- People needed
- 647
- Starts
- 2025-10-27
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2025-12-29
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
- Age ≥5 to <18 years old
You may not qualify if…
- Suspected active tuberculosis in initial assessment (clinical or radiological)
- Current pregnancy or breastfeeding
- Immunocompromised
- Allergy or contraindication to isoniazid or rifapentine
- Chronic liver disease or alcohol use disorder
- History of previous treatment for active or latent tuberculosis infection
- Previous tuberculin skin test
- Household contacts of a tuberculosis index patient with a known or suspected drug-resistant M. tuberculosis strain
- Household contacts or a tuberculosis index patient currently living away from home for more than four weeks
- Household contacts of a tuberculosis index patient who have already received more than 15 daily doses of antituberculous treatment
Where it is running
- Hospital Dr. Carlos Cisterna — Calama, Antofagasta, Chile (enrolling)
- Complejo Asistencial Dr. Sótero Del Río — Puente Alto, Santiago Metropolitan, Chile (enrolling)
- Hospital CRS El Pino — San Bernardo, Santiago Metropolitan, Chile (enrolling)
- Hospital Clínico Félix Bulnes — Santiago, Santiago Metropolitan, Chile (enrolling)
- Hospital Clínico San Borja Arriarán — Santiago, Santiago Metropolitan, Chile (enrolling)
- Hospital San Juan de Dios de Santiago — Santiago, Santiago Metropolitan, Chile
- Hospital Alto Hospicio — Alto Hospicio, Tarapacá, Chile
- Hospital Claudio Vicuña — San Antonio, Valparaiso, Chile
- Hospital Dr. Gustavo Fricke — Viña del Mar, Valparaiso, Chile
- Hospital de Coquimbo — Coquimbo, Coquimbo Region, Chile
- Hospital San Juan de Dios de La Serena — La Serena, Coquimbo Region, Chile
- Hospital de Niños Roberto del Río — Independencia, Santiago Metropolitan, Chile
- Hospital Luis Calvo Mackenna — Providencia, Santiago Metropolitan, Chile
Full record on ClinicalTrials.gov
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