Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

NCT07086820 | Recruiting DMC

• 2 other identifiers: 240519001FONDECYT N° 1250853
• Study Type: interventional
• Target: 647
• Locations: 1 country
• Sites: 13

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. 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. 2.Take weekly isoniazid and rifapentine for 12 weeks if:
3. 3.They are assigned to the intervention arm (regardless of baseline IGRA result), or
4. 4.They are in the control arm and test IGRA-positive at baseline.

Conditions

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

Keywords

Household contacts; Prophylaxis; Tuberculosis infection; Mycobacterium tuberculosis; Children; Adolescent; Randomized clinical trial; Tuberculosis; Cluster-randomized trial

Outcome Measures

Primary Outcomes (1)

• Incidence of new tuberculosis infections (all IGRA conversions) from enrollment until the end of follow-up in both study arms

  At the end of follow-up at 12 weeks (accepted range: ≥ 12 - ≤16 weeks)

Secondary Outcomes (5)

• Incidence of new tuberculosis infections (IGRA conversions) with high IGRA thresholds (IFN-γ ≥1.0 IU/mL) at the end of follow-up in both study arms

  At the end of follow-up at 12 weeks (accepted range ≥12 - ≤16 weeks)

• Incidence of active tuberculosis development until the end of follow-up in both study arms

  From 4 weeks after enrollment to the end of follow-up at 12 weeks (accepted range ≥ 4 - ≤16 weeks)

• Prevalence of tuberculosis infections (all IGRA positive) at the end of follow-up in both study arms

  At the end of follow-up at 12 weeks (accepted range ≥ 12 - ≤16 weeks)

• Incidence of 3HP-related adverse events at 12 weeks in both study arms

  From TPT initiation to completion or last dose received, in both study arms (accepted range ≥ 1 day - ≤16 weeks)

• To evaluate temporal changes in IFN-γ levels between baseline and follow-up among individuals receiving or not receiving tuberculosis preventive treatment

  At the end of follow-up at 12 weeks (accepted range: ≥ 12 - ≤16 weeks)

Study Arms (2)

Standard of care tuberculosis prophylaxis

ACTIVE COMPARATOR

In the Control Arm, only participants with a positive baseline IGRA result will receive tuberculosis preventive treatment (TPT). Therefore, TPT will not be given to participants with a negative baseline IGRA result at enrollment.

Drug: Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Window tuberculosis prophylaxis

EXPERIMENTAL

In the Intervention Arm, all participants will be immediately prescribed tuberculosis preventive treatment (TPT), irrespective of their baseline IGRA result. Therefore, TPT will be given to participants having either positive or negative baseline IGRA results at enrollment.

Drug: Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Interventions

Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks DRUG

Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants.

Also known as: Window prophylaxis, Window period tuberculosis prophylaxis, Universal tuberculosis prophylaxis

Window tuberculosis prophylaxis

Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks DRUG

Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline.

Also known as: Tuberculosis prophylaxis, Chemoprophylaxis, Tuberculosis preventive treatment (TPT)

Standard of care tuberculosis prophylaxis

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
• Age ≥5 to \<18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (13)

Hospital Dr. Carlos Cisterna

Calama, Antofagasta, Chile

RECRUITING

Hospital de Coquimbo

Coquimbo, Coquimbo Region, Chile

NOT YET RECRUITING

Hospital San Juan de Dios de La Serena

La Serena, Coquimbo Region, Chile

NOT YET RECRUITING

Hospital Claudio Vicuña

San Antonio, Región de Valparaíso, Chile

NOT YET RECRUITING

Hospital Dr. Gustavo Fricke

Viña del Mar, Región de Valparaíso, Chile

NOT YET RECRUITING

Hospital de Niños Roberto del Río

Independencia, Santiago Metropolitan, Chile

NOT YET RECRUITING

Hospital Luis Calvo Mackenna

Providencia, Santiago Metropolitan, Chile

NOT YET 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 San Juan de Dios de Santiago

Santiago, Santiago Metropolitan, Chile

NOT YET RECRUITING

Hospital Alto Hospicio

Alto Hospicio, Tarapacá, Chile

NOT YET RECRUITING

MeSH Terms

Conditions

Latent Tuberculosis; Tuberculosis

Interventions

Isoniazid; Chemoprevention

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Intervention Hierarchy (Ancestors)

Hydrazines; Organic Chemicals; Isonicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Drug Therapy; Therapeutics

Central Study Contacts

María Elvira Balcells, MD

CONTACT

+56 955043508; ebalcells@uc.cl

Nicole Le Corre, MD

CONTACT

+56 223546823; mlec@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a multicenter, controlled, cluster-randomized, open-label, superiority trial. A total of 360 households (clusters), each with at least one child aged ≥5 to \<18 years and recently exposed to a new case of pulmonary tuberculosis within the household, will be randomly assigned in a 1:1 allocation ratio to either the intervention or control arm. The intervention consists of a window prophylaxis strategy, while the control involves prophylaxis only for participants with confirmed M. tuberculosis infection. To ensure early enrollment, households will be eligible only if the tuberculosis index patient has received no more than 15 daily doses of antituberculous treatment, for both study arms.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: October 27, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-09

Locations

CL (13)