Tuberculosis InfectionTB-WINNCT07086820
Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
A study testing Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks in people with Tuberculosis Infection and Household Contacts, run by Pontificia Universidad Catolica de Chile at 13 sites in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Tuberculosis Infection, Household Contacts, Children
- What is being tested?
- Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 13 sitesChile
- Study dates
- 27 Oct 2025to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
- Age ≥5 to <18 years old
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
Chile13 sites, 13 recruiting
- Not yet recruiting
Hospital Alto Hospicio
Alto Hospicio, Tarapacá
Sofía De la Barra, MD, sofia.delabarra@hah.gob.cl
Sofía De la Barra, MD
- Recruiting
Hospital Dr. Carlos Cisterna
Calama, Antofagasta
Álvaro Mery, MD, alvaro.mery@redsalud.gob.cl
Álvaro Mery, MD
- Not yet recruiting
Hospital de Coquimbo
Coquimbo, Coquimbo Region
Yasna Bronzic, MD, y.bronzic@gmail.com
Yasna Bronzic, MD
- Not yet recruiting
Hospital de Niños Roberto del Río
Independencia, Santiago Metropolitan
Javiera Kreft, MD, javierakreft@gmail.com
Javiera Kreft, MD
- Not yet recruiting
Hospital San Juan de Dios de La Serena
La Serena, Coquimbo Region
Arlette Andrade, MD, dra.arletteandrade@gmail.com
Arlette Andrade, MD
- Not yet recruiting
Hospital Luis Calvo Mackenna
Providencia, Santiago Metropolitan
Matías Meyer, MD, mmeyer@calvomackenna.cl
Matías Meyer, MD
- Recruiting
Complejo Asistencial Dr. Sótero Del Río
Puente Alto, Santiago Metropolitan
Ricardo Madrid, MD, ricardomadridh@gmail.com
Ricardo Madrid, MD
- Not yet recruiting
Hospital Claudio Vicuña
San Antonio, Valparaiso
Rossana Madrid, MD, rossana.madridm@gmail.com
Rossana Madrid, MD
- Recruiting
Hospital CRS El Pino
San Bernardo, Santiago Metropolitan
Gladys Rojas, MD, gladys.rojas@usach.cl
Gladys Rojas, MD
- Recruiting
Hospital Clínico Félix Bulnes
Santiago, Santiago Metropolitan
María Cecilia Bustamante, MD, mcecilia.bustamante@redsalud.gob.cl
María Cecilia Bustamante, MD
- Recruiting
Hospital Clínico San Borja Arriarán
Santiago, Santiago Metropolitan
Mabel Rivas, MD, mabelrivas@gmail.com
Mabel Rivas, MD
- Not yet recruiting
Hospital San Juan de Dios de Santiago
Santiago, Santiago Metropolitan
Ana María Ramírez, MD, amramirezq@gmail.com
Ana María Ramírez, MD
- Not yet recruiting
Hospital Dr. Gustavo Fricke
Viña del Mar, Valparaiso
María Eugenia Pérez, MD, meperezo64@gmail.com
María Eugenia Pérez, MD
About this study
Official title: Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled 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:
Read more
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:
- 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.
- Take weekly isoniazid and rifapentine for 12 weeks if:
- They are assigned to the intervention arm (regardless of baseline IGRA result), or
- 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.
Read the detailed description
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
- Tuberculosis Infection, Household Contacts, Children, Adolescent, Tuberculosis Infection, Latent, Tuberculosis
- Being tested
- Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks, Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeks
- Keywords
- Household contacts, Prophylaxis, Tuberculosis infection, Mycobacterium tuberculosis, Children, Adolescent, Randomized clinical trial, Tuberculosis, Cluster-randomized trial
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeksDrug
Also called Window prophylaxis, Window period tuberculosis prophylaxis, Universal tuberculosis prophylaxis
Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants.
Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeksDrug
Also called Tuberculosis prophylaxis, Chemoprophylaxis, Tuberculosis preventive treatment (TPT)
Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new tuberculosis infections (all IGRA conversions) from enrollment until the end of follow-up in both study arms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At the end of follow-up at 12 weeks (accepted range: ≥ 12 - ≤16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start27 Oct 2025
- Primary completionMay 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 647 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Elvira Balcells, MD, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086820
- Sponsor's protocol ID
- 240519001
- Other IDs
- FONDECYT N° 1250853
- Acronym
- TB-WIN
- Status last verified
- Sep 2025
- First submitted
- 17 Jul 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Window Prophylaxis for Mycobacterium Tuberculosis Infection Prevention in Child and Adolescent Household Contacts: a Cluster-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07086820
- Acronym / sponsor ID
- TB-WIN / 240519001
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 647 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Take weekly isoniazid and rifapentine for 12 weeks if:
- They are assigned to the intervention arm (regardless of baseline IGRA result), or
- 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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Standard of care tuberculosis prophylaxis | Active comparator | Drug: Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeksIn 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. |
| Window tuberculosis prophylaxis | Experimental | Drug: Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeksIn 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
- Age ≥5 to <18 years old
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeksAlso: Window prophylaxis, Window period tuberculosis prophylaxis, Universal tuberculosis prophylaxisWeekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided to all participants. | Drug | Window tuberculosis prophylaxis |
| Standard of care tuberculosis prophylaxis with weekly rifapentine and isoniazid for 12 weeksAlso: Tuberculosis prophylaxis, Chemoprophylaxis, Tuberculosis preventive treatment (TPT)Weekly isoniazid and rifapentine for 12 weeks (3HP regimen) will be provided only to participants with a positive IGRA result at baseline. | Drug | Standard of care tuberculosis prophylaxis |
Primary outcome
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)
5 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks in people with Tuberculosis Infection and Household Contacts, run by Pontificia Universidad Catolica de Chile at 13 sites in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Elvira Balcells, MD (+56 955043508, ebalcells@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.