Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital

Recruiting

• Conditions: Tuberculosis
• Interventions: Diagnostic Test: IGRA/Tuberculin skin test

• Registration Number: NCT05847491
• Lead Sponsor: Centro Hospitalar do Oeste

Brief Summary

Prospective, descriptive study to assess latent tuberculosis infection (LTBI) among healthcare worker (HCW) in a tertiary hospital in a low-risk area.

Detailed Description

identification and treatment of LTBI can substantially reduce the risk of development of disease and are important TB control strategies, especially in settings with a low tuberculosis (TB) incidence, where reactivation of LTBI often accounts for the majority of non-imported TB disease treatment of LTBI can substantially reduce the risk of development of disease.

In Portugal the real prevalence of LTBI in low-risk HCWs has not been evaluated since they are not included in the periodic screening programs. It is important to diagnose TB infections in HCWs to prevent nosocomial transmission, particularly among immunocompromised patients.

The risk for transmission varies by setting, occupational group, local prevalence of TB, patient population, and effectiveness of TB infection control measures.

Prevention of active TB disease by treatment of LTBI is a critical component for public health.

Tuberculin skin test (TST) is used worldwide to diagnose LTBI, whereas interferon-γ release assay (IGRA) are used in some countries according to their national TB programs. IGRA offers a potential method of serial testing to diagnose LTBI in HCWs, and it has better specificity than that of TST in one-time screening.

Study participants should be identified and contacted by occupational health service. In association, study information should be disseminated through posters and institutional email.

Study Timeline

• Study Start: 2022-09-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Last Update Submitted: 2023-04-27
• Study First Posted: 2023-05-06
• Last Update Posted: 2023-05-06
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• All HCW from our hospital with risk of exposure, working in our hospital for at least 3 consecutive months
• Acceptance to participate and signed informed consent form

Exclusion Criteria

• History of previous tuberculosis
• Active Tuberculosis
• Refusal to sign the informed consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthcare workers	IGRA/Tuberculin skin test	Clinical evaluation, chest x-ray and Interferon-γ release assay (IGRA). Immunocompromised patients will be submitted to a tuberculin skin test. The patients will be evaluated in two or more separate appointments. In the first appointment, patients will be submitted to clinical evaluation and exam request. In the second appointment the results will be evaluated.

Primary Outcome Measures

Name	Time	Method
Number and percentage of latent tuberculosis diagnosis in healthcare workers	1 year	Patients with positive IGRA/tuberculin test screening and without clinical or radiological features of active Tuberculosis

Secondary Outcome Measures

Name	Time	Method
Treatment acceptance for latent tuberculosis	1 year	Number of positive screening participants who accept and start treatment
Treatment completion	1 year	Number of patients who finished treatment

Trial Locations

Locations (1)

Centro Hospitalar do Oeste - Torres Vedras; 🇵🇹 Torres Vedras, Lisboa, Portugal