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Search / Trial NCT07086820

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Jul 17, 2025

Trial Information

Current as of August 22, 2025

Not yet recruiting

Keywords

Household Contacts Prophylaxis Tuberculosis Infection Mycobacterium Tuberculosis Children Adolescent Randomized Clinical Trial Tuberculosis Cluster Randomized Trial

ClinConnect Summary

This clinical trial is studying whether giving preventive tuberculosis medicine right away can stop children and teenagers who live with someone newly diagnosed with active lung tuberculosis from getting infected themselves. The medicine, taken once a week for 12 weeks, is tested to see if it can prevent new infections before they happen, compared to the usual approach where treatment is only given if infection shows up later.

To join the trial, children and teens between 5 and 17 years old who live in the same household as a recently diagnosed tuberculosis patient may be eligible, as long as they don’t have active tuberculosis themselves and don’t have other health issues like pregnancy or liver disease. Participants will have a blood test at the start and again after 12 weeks to check for infection. Those in the treatment group will take the preventive medicine right away, while those in the standard care group will only receive it if they test positive for infection. The goal is to find out if starting treatment early helps keep kids and teens healthy and free from tuberculosis.

Gender

ALL

Eligibility criteria

  • 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

About Pontificia Universidad Catolica De Chile

Pontificia Universidad Católica de Chile is a prestigious academic institution renowned for its commitment to excellence in education, research, and healthcare. As a clinical trial sponsor, the university leverages its extensive expertise in medical sciences to advance innovative research initiatives aimed at improving patient outcomes. With a strong emphasis on ethical standards and scientific rigor, the institution collaborates with multidisciplinary teams to conduct high-quality clinical trials that contribute to the advancement of medical knowledge and the development of effective therapeutic interventions. Its dedication to fostering a culture of inquiry and community engagement positions Pontificia Universidad Católica de Chile as a leader in the field of clinical research in Latin America.

Locations

Santiago, , Chile

Santiago, , Chile

Viña Del Mar, , Chile

Coquimbo, , Chile

Santiago, , Chile

Valparaíso, , Chile

Calama, Antofagasta, Chile

Independencia, Santiago, Chile

Puente Alto, Santiago, Chile

San Bernardo, Santiago, Chile

Alto Hospicio, , Chile

San Antonio, , Chile

Santiago, , Chile

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported