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Airborne Preventive Measures to Reduce New TB Infections in Household Contacts

NCT04938596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2024-05-13

No results posted yet for this study

Summary

Tuberculosis (TB) is currently one of the top 10 causes of death worldwide and the leading cause of death from a single infectious agent (ranking above HIV/AIDS). The investigators hypothesize that reducing respiratory exposure within the household, during the first weeks of TB treatment initiation of the index case, can reduce new TB infections in close contacts. For this purpose, a pilot, controlled, pre-post study will be set up, to evaluate the feasibility of implementing a bundle of respiratory precautions to all household contacts of new pulmonary TB cases, compared to standard of care, in primary health care in a high TB incidence area in Santiago, Chile.

Conditions

Interventions

COMBINATION_PRODUCT

Respiratory bundle

* Provision of N95 masks and strong recommendation of use to all household contacts and the index case when sharing a room together, for 2 weeks * Recommendation to index case to sleep in a room alone, with the door closed and avoid sharing room with others during 2 weeks * Promotion of strategies to improve house ventilation during 2 weeks * Provision of a TB leaflet and nurse education about TB transmission.

Sponsors & Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    collaborator OTHER_GOV

  • Agencia Nacional de Investigación y Desarrollo

    collaborator OTHER

  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • María Elvira Balcells, MD; MSc · School of Medicine. Pontificia Universidad Católica de Chile.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • Chile

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04938596 on ClinicalTrials.gov