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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 17
Healthy Volunteers: f
View:

• Household contacts of patient (index case) with a new diagnosis of microbiologically confirmed pulmonary tuberculosis

• Age ≥5 to \<18 years old

Locations
Other Locations
Chile
Hospital Alto Hospicio
NOT_YET_RECRUITING
Alto Hospicio
Hospital Dr. Carlos Cisterna
RECRUITING
Calama
Hospital de Coquimbo
NOT_YET_RECRUITING
Coquimbo
Hospital de Niños Roberto del Río
NOT_YET_RECRUITING
Independencia
Hospital San Juan de Dios de La Serena
NOT_YET_RECRUITING
La Serena
Hospital Luis Calvo Mackenna
NOT_YET_RECRUITING
Providencia
Complejo Asistencial Dr. Sótero Del Río
RECRUITING
Puente Alto
Hospital Claudio Vicuña
NOT_YET_RECRUITING
San Antonio
Hospital CRS El Pino
RECRUITING
San Bernardo
Hospital Clínico Félix Bulnes
RECRUITING
Santiago
Hospital Clínico San Borja Arriarán
RECRUITING
Santiago
Hospital San Juan de Dios de Santiago
NOT_YET_RECRUITING
Santiago
Hospital Dr. Gustavo Fricke
NOT_YET_RECRUITING
Viña Del Mar
Contact Information
Primary
María Elvira Balcells, MD
ebalcells@uc.cl
+56 955043508
Backup
Nicole Le Corre, MD
mlec@uc.cl
+56 223546823
Time Frame
Start Date: 2025-10-27
Estimated Completion Date: 2028-11
Participants
Target number of participants: 647
Treatments
Active_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Pontificia Universidad Catolica de Chile

This content was sourced from clinicaltrials.gov