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

NCT05847491 | Unknown DMC

• 1 other identifier: LTBCHO23
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tuberculosis

Keywords

Latent Tuberculosis; Healthcare workers; IGRA

Outcome Measures

Primary Outcomes (1)

• Number and percentage of latent tuberculosis diagnosis in healthcare workers

  Patients with positive IGRA/tuberculin test screening and without clinical or radiological features of active Tuberculosis

  1 year

Secondary Outcomes (2)

• Treatment acceptance for latent tuberculosis

  1 year

• Treatment completion

  1 year

Other Outcomes (1)

• Treatment discontinuation

  1 year

Study Arms (1)

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

Interventions

IGRA/Tuberculin skin test DIAGNOSTIC_TEST

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

Healthcare workers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Medical staff, nurses, laboratory, cardiopulmonary and radiology technician, operational staff from our hospital working for 3 or more months.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Hospitalar do Oeste: lead

Study Sites (1)

Centro Hospitalar do Oeste - Torres Vedras

Torres Vedras, Lisbon District, 2560-295, Portugal

RECRUITING

Related Publications (6)

• Adams S, Ehrlich R, Baatjies R, van Zyl-Smit RN, Said-Hartley Q, Dawson R, Dheda K. Incidence of occupational latent tuberculosis infection in South African healthcare workers. Eur Respir J. 2015 May;45(5):1364-73. doi: 10.1183/09031936.00138414. Epub 2015 Feb 19.

  PMID: 25700382 BACKGROUND

• Almufty HB, Abdulrahman IS, Merza MA. Latent Tuberculosis Infection among Healthcare Workers in Duhok Province: From Screening to Prophylactic Treatment. Trop Med Infect Dis. 2019 May 23;4(2):85. doi: 10.3390/tropicalmed4020085.

  PMID: 31126022 BACKGROUND

• Apriani L, McAllister S, Sharples K, Alisjahbana B, Ruslami R, Hill PC, Menzies D. Latent tuberculosis infection in healthcare workers in low- and middle-income countries: an updated systematic review. Eur Respir J. 2019 Apr 18;53(4):1801789. doi: 10.1183/13993003.01789-2018. Print 2019 Apr.

  PMID: 30792341 BACKGROUND

• Chen B, Gu H, Wang X, Wang F, Peng Y, Ge E, Upshur R, Dai R, Wei X, Jiang J. Prevalence and determinants of latent tuberculosis infection among frontline tuberculosis healthcare workers in southeastern China: A multilevel analysis by individuals and health facilities. Int J Infect Dis. 2019 Feb;79:26-33. doi: 10.1016/j.ijid.2018.11.010. Epub 2018 Nov 22.

  PMID: 30471404 BACKGROUND

• Costa JC, Silva R, Ferreira J, Nienhaus A. Active tuberculosis among health care workers in Portugal. J Bras Pneumol. 2011 Sep-Oct;37(5):636-45. doi: 10.1590/s1806-37132011000500011. English, Portuguese.

  PMID: 22042396 BACKGROUND

• Park Y, Kim SY, Kim JW, Park MS, Kim YS, Chang J, Kang YA. Serial testing of healthcare workers for latent tuberculosis infection and long-term follow up for development of active tuberculosis. PLoS One. 2018 Sep 20;13(9):e0204035. doi: 10.1371/journal.pone.0204035. eCollection 2018.

  PMID: 30235272 BACKGROUND

MeSH Terms

Conditions

Tuberculosis; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Carina Rolo Silvestre, MD, MSc

  Centro Hospitalar do Oeste

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carina Rolo Silvestre, MD, MSc

CONTACT

+351261319300; carina.silvestre@choeste.min-saude.pt

Ricardo Cordeiro, MD

CONTACT

+35261319300; ricardo.cordeiro@choeste.min-saude.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: September 1, 2022
• Primary Completion: September 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After publication.
• Access Criteria: By request to the authors.

Locations

PT (1)