Actively Recruiting

Phase Not Applicable
Age: 5Years - 17Years
All Genders
NCT07086820

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-12-29

647

Participants Needed

13

Research Sites

157 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Who Can Participate

Age: 5Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Household contacts of a patient newly diagnosed with microbiologically confirmed pulmonary tuberculosis
  • Age 5 to less than 18 years old
Not Eligible

You will not qualify if you...

  • Suspected active tuberculosis based on clinical or radiological assessment
  • Current pregnancy or breastfeeding
  • Immunocompromised status
  • 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 tuberculosis patients with known or suspected drug-resistant Mycobacterium tuberculosis
  • Household contacts or tuberculosis patients currently living away from home for more than four weeks
  • Household contacts of tuberculosis patients who have already received more than 15 daily doses of antituberculous treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 13 locations

1

Hospital Dr. Carlos Cisterna

Calama, Antofagasta, Chile

Actively Recruiting

2

Hospital de Coquimbo

Coquimbo, Coquimbo Region, Chile

Not Yet Recruiting

3

Hospital San Juan de Dios de La Serena

La Serena, Coquimbo Region, Chile

Not Yet Recruiting

4

Hospital de Niños Roberto del Río

Independencia, Santiago Metropolitan, Chile

Not Yet Recruiting

5

Hospital Luis Calvo Mackenna

Providencia, Santiago Metropolitan, Chile

Not Yet Recruiting

6

Complejo Asistencial Dr. Sótero Del Río

Puente Alto, Santiago Metropolitan, Chile

Actively Recruiting

7

Hospital CRS El Pino

San Bernardo, Santiago Metropolitan, Chile

Actively Recruiting

8

Hospital Clínico Félix Bulnes

Santiago, Santiago Metropolitan, Chile

Actively Recruiting

9

Hospital Clínico San Borja Arriarán

Santiago, Santiago Metropolitan, Chile

Actively Recruiting

10

Hospital San Juan de Dios de Santiago

Santiago, Santiago Metropolitan, Chile

Not Yet Recruiting

11

Hospital Alto Hospicio

Alto Hospicio, Tarapacá, Chile

Not Yet Recruiting

12

Hospital Claudio Vicuña

San Antonio, Valparaiso, Chile

Not Yet Recruiting

13

Hospital Dr. Gustavo Fricke

Viña del Mar, Valparaiso, Chile

Not Yet Recruiting

Loading map...

Research Team

M

María Elvira Balcells, MD

CONTACT

N

Nicole Le Corre, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here