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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis - Age ≥5 to \<18 years old Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis * Age ≥5 to \<18 years old Exclusion Criteria: * 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

Treatments Being Tested

DRUG

Tuberculosis 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.

DRUG

Standard 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 Claudio Vicuña
San Antonio, Región de Valparaíso, Chile
Hospital Dr. Gustavo Fricke
Viña del Mar, Región de Valparaíso, 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