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Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

NCT07086820 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 647

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • Tuberculosis Infection
  • Household Contacts
  • Children
  • Adolescent
  • Tuberculosis Infection, Latent
  • Tuberculosis

Interventions

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.

Sponsors & Collaborators

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-27
Primary Completion
2028-05-31
Completion
2028-11-30

Countries

  • Chile

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07086820 on ClinicalTrials.gov