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Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

RecruitingNAAges 5 Years - 17 YearsAllPontificia Universidad Catolica de Chile
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In plain words

What the trial is, and whether it could suit you

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-

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks
  • Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks
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Where

13 sites
Hospital Dr. Carlos Cisterna
Calama, Chile
Hospital de Coquimbo
Coquimbo, Chile
Hospital San Juan de Dios de La Serena
La Serena, Chile
Hospital de Niños Roberto del Río
Independencia, Chile
Hospital Luis Calvo Mackenna
Providencia, Chile
Complejo Asistencial Dr. Sótero Del Río
Puente Alto, Chile
Hospital CRS El Pino
San Bernardo, Chile
Hospital Clínico Félix Bulnes
Santiago, Chile

…and 5 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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