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

NCT ID: NCT05847491

Last Updated: 2023-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

IGRA/Tuberculin skin test

Intervention Type DIAGNOSTIC_TEST

All patients will receive:

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

Interventions

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IGRA/Tuberculin skin test

All patients will receive:

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centro Hospitalar do Oeste

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carina Rolo Silvestre, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar do Oeste

Locations

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Centro Hospitalar do Oeste - Torres Vedras

Torres Vedras, Lisbon District, Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Carina Rolo Silvestre, MD, MSc

Role: CONTACT

+351261319300 ext. 3231

Ricardo Cordeiro, MD

Role: CONTACT

+35261319300 ext. 3231

Facility Contacts

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Carina Rolo Silvestre, MD, MSc

Role: primary

+351261319300 ext. 3231

Ricardo Cordeiro, MD

Role: backup

+351261319300 ext. 3231

References

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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.

Reference Type BACKGROUND
PMID: 25700382 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31126022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30792341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30471404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22042396 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30235272 (View on PubMed)

Other Identifiers

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LTBCHO23

Identifier Type: -

Identifier Source: org_study_id

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