Airborne Preventive Measures to Reduce New TB Infections in Household Contacts

NCT04938596 | Completed

• 1 other identifier: 1211225
• Study Type: interventional
• Target: 432
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis, Pulmonary; Household Contacts; Tuberculosis

Outcome Measures

Primary Outcomes (4)

• Participation rate

  To document the proportion of TB cases and household contacts who agree to participate as measured by enrollment.

  2 weeks

• Study compliance

  To document participants compliance with the respiratory bundle as measured by a previously validated adherence questionnaire.

  2 weeks

• Completion rate

  The number of participants assessable at end of follow-up.

  12 weeks

• Acceptability of the intervention

  Focus group evaluation (participants and TB nurses perspectives, qualitative outcome).

  12 weeks

Secondary Outcomes (1)

• New tuberculosis infections

  12 weeks

Study Arms (2)

Respiratory Bundle Group

EXPERIMENTAL

The intervention consists of a bundle of measures for respiratory transmission prevention that will be provided during the first 2 weeks of TB treatment of index case.

Combination Product: Respiratory bundle

Standard of care

NO INTERVENTION

Under current national guidelines, no systematic recommendation regarding respiratory protection is given for household contacts of TB cases.

Interventions

Respiratory bundle COMBINATION_PRODUCT

* 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.

Respiratory Bundle Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all household contacts of a new case of pulmonary TB (smear, culture or PCR positive) newly diagnosed at each clinic.

You may not qualify if:

• household contacts found to have co-prevalent active TB at enrolment
• household contacts planning to leave the house at the time of enrolment
• household contacts of index cases having already initiated TB treatment for \> 48h
• household contacts of index cases that are currently hospitalized

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator
• Agencia Nacional de Investigación y Desarrollo: collaborator

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, Chile

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• María Elvira Balcells, MD; MSc

  School of Medicine. Pontificia Universidad Católica de Chile.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, semi-experimental, controlled trial. Two different health care areas of Santiago (and their corresponding TB clinics) will be allocated to control or intervention arm; after a baseline pre-intervention period.

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: June 24, 2021
• Study Start: October 4, 2021
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

CL (1)