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

Sponsor
Centro Hospitalar do Oeste (Other)
Overall Status
Recruiting
CT.gov ID
NCT05847491
Collaborator
(none)
100
1
16
6.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: IGRA/Tuberculin skin test

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 Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital
Actual Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Healthcare workers

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.

Diagnostic Test: IGRA/Tuberculin skin test
All patients will receive: Clinical evaluation; Chest x-ray. IGRA (or tuberculin skin test if immunocompromised) Therapeutic proposal if eligible

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Treatment acceptance for latent tuberculosis [1 year]

    Number of positive screening participants who accept and start treatment

  2. Treatment completion [1 year]

    Number of patients who finished treatment

Other Outcome Measures

  1. Treatment discontinuation [1 year]

    Number of patients who did not complete treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centro Hospitalar do Oeste - Torres Vedras Torres Vedras Lisboa Portugal 2560-295

Sponsors and Collaborators

  • Centro Hospitalar do Oeste

Investigators

  • Principal Investigator: Carina Rolo Silvestre, MD, MSc, Centro Hospitalar do Oeste

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centro Hospitalar do Oeste
ClinicalTrials.gov Identifier:
NCT05847491
Other Study ID Numbers:
  • LTBCHO23
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centro Hospitalar do Oeste
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 6, 2023