BridgeMD
Prevention study for Tuberculosis Infection
Official title Window Prophylaxis for Pediatric Tuberculosis Prevention Trial
ClinicalTrials.gov ID: NCT07086820
What this study is testing
What is Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks?
Tuberculosis window prophylaxis with weekly rifapentine and isoniazid for 12 weeks is an investigational medicine, given as an once-weekly, being studied as a potential treatment for tuberculosis infection.
Also referred to as Window prophylaxis, Window period tuberculosis prophylaxis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
- Age ≥5 to \<18 years old
You likely can't join 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
See the full eligibility criteria
- Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis
- Age ≥5 to \<18 years old
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calama, Antofagasta, Chile
- Coquimbo, Coquimbo Region, Chile
- La Serena, Coquimbo Region, Chile
- Independencia, Santiago Metropolitan, Chile
- Providencia, Santiago Metropolitan, Chile
- Puente Alto, Santiago Metropolitan, Chile
- San Bernardo, Santiago Metropolitan, Chile
- Santiago, Santiago Metropolitan, Chile
- Alto Hospicio, Tarapacá, Chile
- San Antonio, Valparaiso, Chile
- Viña del Mar, Valparaiso, Chile
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calama, Antofagasta, Chile; Coquimbo, Coquimbo Region, Chile; La Serena, Coquimbo Region, Chile; Independencia, Santiago Metropolitan, Chile; Providencia, Santiago Metropolitan, Chile; Puente Alto, Santiago Metropolitan, Chile and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.