RecruitingNot ApplicableNCT07086820

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

647 participants

Start Date

Oct 27, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 5 YearsMax Age: 17 Years

Inclusion Criteria2

  • Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
  • Age ≥5 to <18 years old

Exclusion Criteria10

  • 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

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Interventions

DRUGTuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants.

DRUGStandard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline.


Locations(13)

Hospital Dr. Carlos Cisterna

Calama, Antofagasta, 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

Complejo Asistencial Dr. Sótero Del Río

Puente Alto, Santiago Metropolitan, Chile

Hospital CRS El Pino

San Bernardo, Santiago Metropolitan, Chile

Hospital Clínico Félix Bulnes

Santiago, Santiago Metropolitan, Chile

Hospital Clínico San Borja Arriarán

Santiago, Santiago Metropolitan, Chile

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

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NCT07086820


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