Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

647 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-27

Study Completion Date

2028-11-30

Brief Summary

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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.

Detailed Description

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Mycobacterium tuberculosis acquisition following exposure is a common occurrence, but it remains challenging to diagnose, often requiring serial testing, as immunological responses (e.g., tuberculin skin test or interferon-gamma release assays) can take weeks to provide evidence of infection. Although tuberculosis infection is generally asymptomatic, research has shown that active mycobacterial replication and inflammation occur, and its long-term effects are not well understood due to the complexity of host-pathogen interactions and delayed disease progression. While antituberculosis prophylaxis has traditionally aimed at preventing the progression from established tuberculosis infection to active tuberculosis disease, recent studies suggest that prophylaxis administered during the "window period" after exposure may also prevent its acquisition, particularly in very young children.

This trial will help determine the effectiveness of tuberculosis prophylaxis administered during the window period in preventing the acquisition of tuberculosis infection in children and adolescents exposed in household settings. If successful, the findings may inform broader strategies for tuberculosis prevention, particularly in reducing reservoirs of Mycobacterium tuberculosis and contributing to the global tuberculosis elimination efforts.

Conditions

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Tuberculosis Infection Household Contacts Children Adolescent Tuberculosis Infection, Latent Tuberculosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard of care tuberculosis prophylaxis

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Window tuberculosis prophylaxis

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.

Group Type EXPERIMENTAL

Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Window prophylaxis Window period tuberculosis prophylaxis Universal tuberculosis prophylaxis Tuberculosis prophylaxis Chemoprophylaxis Tuberculosis preventive treatment (TPT)

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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María Elvira Balcells, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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María Elvira Balcells, MD

Role: CONTACT

Phone: +56 955043508

Email: [email protected]

Nicole Le Corre, MD

Role: CONTACT

Phone: +56 223546823

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

240519001

Identifier Type: -

Identifier Source: org_study_id

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Standard of care tuberculosis prophylaxis

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

Window tuberculosis prophylaxis

Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks

Interventions

Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks

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

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Pontificia Universidad Catolica de Chile

Responsible Party

María Elvira Balcells, MD

Locations

Hospital Dr. Carlos Cisterna

Hospital de Coquimbo

Hospital San Juan de Dios de La Serena

Hospital Claudio Vicuña

Hospital Dr. Gustavo Fricke

Hospital de Niños Roberto del Río

Hospital Luis Calvo Mackenna

Complejo Asistencial Dr. Sótero Del Río

Hospital CRS El Pino

Hospital Clínico Félix Bulnes

Hospital Clínico San Borja Arriarán

Hospital San Juan de Dios de Santiago

Hospital Alto Hospicio

Countries

Central Contacts

María Elvira Balcells, MD

Nicole Le Corre, MD

Facility Contacts

Álvaro Mery, MD

Yasna Bronzic, MD

Arlette Andrade, MD

Rossana Madrid, MD

María Eugenia Pérez, MD

Javiera Kreft, MD

Matías Meyer, MD

Ricardo Madrid, MD

Gladys Rojas, MD

María Cecilia Bustamante, MD

Mabel Rivas, MD

Ana María Ramírez, MD

Sofía De la Barra, MD

Other Identifiers

FONDECYT N° 1250853

240519001