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NCT Number: NCT07086820

Window Prophylaxis for Pediatric Tuberculosis Prevention Trial

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.

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Key information

Conditions

Tuberculosis Infection Actinomycetales Infections Adolescent Bacterial Infections Bacterial Infections and Mycoses Children Gram-Positive Bacterial Infections Household Contacts Infections Latent Infection Latent Tuberculosis Mycobacterium Infections Tuberculosis Tuberculosis Infection, Latent

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Dr. Carlos Cisterna, Calama, Antofagasta, Chile

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Window prophylaxis, Window period tuberculosis prophylaxis, Universal 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.

Other names: Tuberculosis prophylaxis, Chemoprophylaxis, Tuberculosis preventive treatment (TPT)

Primary outcomes

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

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

Secondary outcomes

  1. 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

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

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

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

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

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

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

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

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

María Elvira Balcells, MD

CONTACT

[email protected]

+56 955043508

Nicole Le Corre, MD

CONTACT

[email protected]

+56 223546823

Sponsors and collaborators

Lead sponsor

Pontificia Universidad Catolica de Chile

Other

Registry information

Official study title

Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial

Acronym: TB-WIN

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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