Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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