Window-period preventive treatment to prevent TB infection in children and adolescents.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This cluster-randomized controlled trial enrolls household contacts aged 5 to <18 years of microbiologically confirmed pulmonary TB cases and uses baseline and 12-week QuantiFERON-TB Gold Plus IGRA testing to detect new infection. Participants in the intervention arm receive weekly isoniazid and rifapentine for 12 weeks starting during the post-exposure 'window period', while the control arm follows standard care where TPT is not offered to IGRA-negative contacts. The primary outcome is IGRA conversion at 12 weeks, comparing incidence between immediate TPT and standard care clusters. The trial is conducted at regional hospitals in Chile with clinical screening to exclude active TB, pregnancy, immunosuppression, drug-resistant exposure, or contraindications to study drugs.

Why it matters

Who can join: the full rules

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

Where it's running

• Hospital Dr. Carlos Cisterna
  Calama, Antofagasta, Chile Recruiting
• Complejo Asistencial Dr. Sótero Del Río
  Puente Alto, Santiago Metropolitan, Chile Recruiting
• Hospital CRS El Pino
  San Bernardo, Santiago Metropolitan, Chile Recruiting
• Hospital Clínico Félix Bulnes
  Santiago, Santiago Metropolitan, Chile Recruiting
• Hospital Clínico San Borja Arriarán
  Santiago, Santiago Metropolitan, Chile Recruiting
• Hospital de Coquimbo
  Coquimbo, Coquimbo Region, Chile Not yet recruiting

Study contacts

• Study coordinator: María Elvira Balcells, MD
• Email: ebalcells@uc.cl
• Phone: +56 955043508

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Doxycycline added to standard treatment for central nervous system tuberculosis

  This trial tests whether adding doxycycline to standard anti‑TB therapy and corticosteroids helps adults with central nervous system tuberculosis live longer or have less severe neurological disability.

  Recruiting at 5 sites Phase 2 National University Hospital, Singapore · Medan, Medan and 5 other locations · NCT06446245

• Understanding TB Infection Risks in Health Workers

  This study is trying to understand how health workers in Cape Town respond to tuberculosis infections over a year to find better ways to protect them from getting sick.

  Recruiting Beth Israel Deaconess Medical Center · Cape Town · NCT06221488

• Examining Latent Tuberculosis Infection in Health-care Workers and Students

  This study looks at how many health care workers and students have Latent Tuberculosis Infection without symptoms and what factors might put them at risk.

  Recruiting Catholic University of the Sacred Heart · Roma · NCT05756582

• Biomarker Test for Diagnosis and Monitoring of Extrapulmonary Tuberculosis

  This study tests biomarker-based methods to help diagnose extrapulmonary TB and monitor treatment in adults, including people living with HIV, using samples from affected sites in Kenya.

  Recruiting at 2 sites Nagasaki University · Nairobi and 1 other locations · NCT07901387

• Short-Course TB Treatment for Children with Non-Severe Pulmonary TB

  This trial tests two shorter-treatment options for kids with non-severe pulmonary TB to see if they can clear the infection as well as the standard 6-month plan.

  Recruiting at 13 sites Phase 2 Huashan Hospital · Fuzhou, Fujian and 12 other locations · NCT07893444

• Combined oral contraceptive timing with Ganfeborole in healthy women

  This study tests how the contraceptive Microgynon behaves in the body when given alone and with Ganfeborole in healthy women who can’t get pregnant.

  Recruiting Phase 1 GlaxoSmithKline · Madrid · NCT07784894

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.