NCT07086820 Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
| NCT ID | NCT07086820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Tuberculosis Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 647 participants |
| Start Date | 2025-10-27 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 647 participants in total. It began in 2025-10-27 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07086820 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 17 Years, studying Tuberculosis Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07086820 currently recruiting?
Yes, NCT07086820 is actively recruiting participants. Contact the research team at ebalcells@uc.cl for enrollment information.
Where is the NCT07086820 trial being conducted?
This trial is being conducted at Calama, Chile, Coquimbo, Chile, La Serena, Chile, Independencia, Chile and 9 additional locations.
Who is sponsoring the NCT07086820 clinical trial?
NCT07086820 is sponsored by Pontificia Universidad Catolica de Chile. The trial plans to enroll 647 participants.