Clinical trial

Strengthening of Airborne Preventive Measures Inside Households of Pulmonary TB Cases as a Tool to Reduce New Infections in Close Contacts. A Pilot, Controlled, Pre-post Study.

Name

1211225

Description

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.

Trial arms

Trial start

2021-10-04

Estimated PCD

2024-03-30

Trial end

2024-03-30

Status

Completed

Treatment

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.

Arms:

Respiratory Bundle Group

Size

432

Primary endpoint

Participation rate

2 weeks

Study compliance

2 weeks

Completion rate

12 weeks

Acceptability of the intervention

12 weeks

Eligibility criteria

Inclusion Criteria: * all household contacts of a new case of pulmonary TB (smear, culture or PCR positive) newly diagnosed at each clinic. Exclusion Criteria: * 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, semi-experimental, controlled trial.\n\nTwo 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.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 432, 'type': 'ACTUAL'}}

Updated at

2024-05-13

1 organization

1 product

3 indications

Organization

Pontificia Universidad Catolica de Chile

Product

Indication

Indication

Indication