Preventive tuberculosis treatment for children and adolescents in households with a new tuberculosis case
Tests early preventive tuberculosis treatment in children and teens living with a newly diagnosed patient.
Plain-language title generated from the registry record
Registry title: Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
Key facts
- Where
- Alto Hospicio, Calama, Coquimbo, Independencia, La Serena, Providencia, Puente Alto, San Antonio, San Bernardo, Santiago, and Viña del Mar, ChileSee the 13 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 5 and 17 years old?
Source: NCT07086820, who can take part
Where in Chile
- Hospital Alto HospicioAlto Hospicio, ChileNot yet recruiting
- Hospital Dr. Carlos CisternaCalama, ChileTaking people
- Hospital de CoquimboCoquimbo, ChileNot yet recruiting
- Hospital de Niños Roberto del RíoIndependencia, ChileNot yet recruiting
- Hospital San Juan de Dios de La SerenaLa Serena, ChileNot yet recruiting
- Hospital Luis Calvo MackennaProvidencia, ChileNot yet recruiting
- Complejo Asistencial Dr. Sótero Del RíoPuente Alto, ChileTaking people
- Hospital Claudio VicuñaSan Antonio, ChileNot yet recruiting
- Hospital CRS El PinoSan Bernardo, ChileTaking people
- Hospital Clínico Félix BulnesSantiago, ChileTaking people
- Hospital Clínico San Borja ArriaranSantiago, ChileTaking people
- Hospital San Juan de Dios de SantiagoSantiago, ChileNot yet recruiting
- Hospital Dr. Gustavo FrickeViña del Mar, ChileNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pontificia Universidad Catolica de Chile
- Trial code
- NCT07086820
- Record updated
- 29 December 2025
- Original description
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.Read full original descriptionShow less
Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial
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.
Inclusion: Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis; Age ≥5 to <18 years old.
Exclusion: History of previous treatment for active or latent tuberculosis infection; Previous tuberculin skin test; Household contacts of a tuberculosis index patient who have already received more than 15 daily doses of antituberculous treatment; Suspected active tuberculosis in initial assessment (clinical or radiological); Allergy or contraindication to isoniazid or rifapentine; Chronic liver disease or alcohol use disorder; 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; Current pregnancy or breastfeeding; Immunocompromised.