TuberculosisNCT05847491
Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital
An observational study of Tuberculosis, run by Centro Hospitalar do Oeste at 1 site in Portugal.
Trial summary
Prospective, descriptive study to assess latent tuberculosis infection (LTBI) among healthcare worker (HCW) in a tertiary hospital in a low-risk area. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- IGRA/Tuberculin skin test
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical staff, nurses, laboratory, cardiopulmonary and radiology technician, operational staff from our hospital working for 3 or more months.
Who may be able to join
- 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
Who cannot join
- History of previous tuberculosis
- Active Tuberculosis
- Refusal to sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Centro Hospitalar do Oeste - Torres Vedras
Torres Vedras, Lisbon District, 2560-295
Carina Rolo Silvestre, MD, MSc, +351261319300 ext. 3231, carina.silvestre@choeste.min-saude.pt
Ricardo Cordeiro, MD, +351261319300 ext. 3231, ricardo.cordeiro@choeste.min-saude.pt
About this study
Prospective, descriptive study to assess latent tuberculosis infection (LTBI) among healthcare worker (HCW) in a tertiary hospital in a low-risk area.
Read the 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.
- Conditions
- Tuberculosis
- Being tested
- IGRA/Tuberculin skin test
- Keywords
- Latent Tuberculosis, Healthcare workers, IGRA
- Medical subject headings
- Tuberculosis, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGRA/Tuberculin skin testDiagnostic test
All patients will receive:
- Clinical evaluation;
- Chest x-ray.
- IGRA (or tuberculin skin test if immunocompromised)
- Therapeutic proposal if eligible
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: IGRA/Tuberculin skin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (2)
Treatment acceptance for latent tuberculosis
Number of positive screening participants who accept and start treatment
Measured: 1 year
Treatment completion
Number of patients who finished treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Sep 2022
- Primary completion30 Sep 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar do Oeste
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carina Rolo Silvestre, MD, MSc, Principal investigator, Centro Hospitalar do Oeste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847491
- Sponsor's protocol ID
- LTBCHO23
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data (IPD) that underlie results in a publication.
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.
PubMed 25700382Almufty 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.
PubMed 31126022Apriani 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.
PubMed 30792341Chen 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.
PubMed 30471404Costa 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.
PubMed 22042396Park 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.
PubMed 30235272
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latent Tuberculosis in Healthcare Workers - the Reality of a Portuguese Tertiary Hospital
- ClinicalTrials.gov ID
- NCT05847491
- Acronym / sponsor ID
- LTBCHO23
- Conditions
- Tuberculosis
- Keywords
- Latent Tuberculosis, Healthcare workers, IGRA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centro Hospitalar do OesteUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare workers | – | Diagnostic Test: IGRA/Tuberculin skin testClinical 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical staff, nurses, laboratory, cardiopulmonary and radiology technician, operational staff from our hospital working for 3 or more months.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- History of previous tuberculosis
- Active Tuberculosis
- Refusal to sign the informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGRA/Tuberculin skin testAll patients will receive: * Clinical evaluation; * Chest x-ray. * IGRA (or tuberculin skin test if immunocompromised) * Therapeutic proposal if eligible | Diagnostic test | Healthcare workers |
Primary outcome
Number and percentage of latent tuberculosis diagnosis in healthcare workers
Time frame: 1 year
Patients with positive IGRA/tuberculin test screening and without clinical or radiological features of active Tuberculosis
2 secondary outcomes
Treatment acceptance for latent tuberculosis
Time frame: 1 year
Treatment completion
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 25700382Adams 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.
- Background: PubMed 31126022Almufty 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.
- Background: PubMed 30792341Apriani 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.
- Background: PubMed 30471404Chen 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.
- Background: PubMed 22042396Costa 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.
- Background: PubMed 30235272Park 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.
- Individual participant dataSharing planned: Yes. All individual participant data (IPD) that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carina Rolo Silvestre, MD, MSc principal investigator
Centro Hospitalar do Oeste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Centro Hospitalar do Oeste at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carina Rolo Silvestre, MD, MSc (+351261319300 ext. 3231, carina.silvestre@choeste.min-saude.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of latent tuberculosis diagnosis in healthcare workers (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05847491, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.