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

Tuberculosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05847491
• Other study ID #: LTBCHO23
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Centro Hospitalar do Oeste
• Contact: Carina Rolo Silvestre, MD, MSc
• Phone: +351261319300
• Email: carina.silvestre[@]choeste.min-saude.pt
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Latent Tuberculosis
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Portugal	Centro Hospitalar do Oeste - Torres Vedras	Torres Vedras	Lisboa

Sponsors (1)

Lead Sponsor	Collaborator
Centro Hospitalar do Oeste

Country where clinical trial is conducted

Portugal, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment discontinuation	Number of patients who did not complete treatment	1 year
Primary	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	Treatment acceptance for latent tuberculosis	Number of positive screening participants who accept and start treatment	1 year
Secondary	Treatment completion	Number of patients who finished treatment	1 year