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

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

Study Overview

• Status: Recruiting
• Conditions: Tuberculosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Carina Rolo Silvestre, MD, MSc; Phone Number: 3231 +351261319300; Email: carina.silvestre@choeste.min-saude.pt
• Study Contact Backup: Name: Ricardo Cordeiro, MD; Phone Number: 3231 +35261319300; Email: ricardo.cordeiro@choeste.min-saude.pt

Study Locations

• Portugal
  • Lisboa
    • Torres Vedras, Lisboa, Portugal, 2560-295
      • Recruiting
      • Centro Hospitalar do Oeste - Torres Vedras
      • Contact: Carina Rolo Silvestre, MD, MSc; Phone Number: 3231 +351261319300; Email: carina.silvestre@choeste.min-saude.pt
      • Contact: Ricardo Cordeiro, MD; Phone Number: 3231 +351261319300; Email: ricardo.cordeiro@choeste.min-saude.pt
      • Sub-Investigator: Maria João Cavaco, MD
      • Sub-Investigator: Ricardo Cordeiro, MD
      • Principal Investigator: Carina Rolo Silvestre, MD, MSc
      • Sub-Investigator: André Nunes, MD
      • Sub-Investigator: Luis Mateus, MD
      • Sub-Investigator: Sofia Fontão, MD
      • Sub-Investigator: Natália André, MD
      • Sub-Investigator: Teresa Falcão, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment acceptance for latent tuberculosis	Number of positive screening participants who accept and start treatment	1 year
Treatment completion	Number of patients who finished treatment	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment discontinuation	Number of patients who did not complete treatment	1 year

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Estimate): May 8, 2023

Study Record Updates

• Last Update Posted (Estimate): May 8, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Latent Tuberculosis; IGRA; Healthcare workers
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Latent Infection; Tuberculosis; Latent Tuberculosis
• Other Study ID Numbers: LTBCHO23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All individual participant data (IPD) that underlie results in a publication.
• IPD Sharing Time Frame: After publication.
• IPD Sharing Access Criteria: By request to the authors.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No