Clinical trial NCT05847491: Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital
Official title: Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tuberculosis
Keywords: Latent Tuberculosis
Healthcare workers
IGRA
Lead sponsor: Centro Hospitalar do Oeste
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and percentage of latent tuberculosis diagnosis in healthcare workers
timeFrame: 1 year
Secondary outcomes:
measure: Treatment acceptance for latent tuberculosis
timeFrame: 1 year
measure: Treatment completion
timeFrame: 1 year
Other outcomes:
measure: Treatment discontinuation
timeFrame: 1 year
Locations:
city: Torres Vedras
country: Portugal
facility: Centro Hospitalar do Oeste - Torres Vedras
state: Lisboa
Study officials:
affiliation: Centro Hospitalar do Oeste
name: Carina Rolo Silvestre, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.
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.
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.