NCT01376843

Brief Summary

The purpose of this study is to access conversion rate of TST (Tuberculin skin test) and Quantiferon-TB Gold In tube assay in health care workers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

11 months

First QC Date

June 16, 2011

Last Update Submit

March 4, 2013

Conditions

Keywords

latent tuberculosis in health care workers

Outcome Measures

Primary Outcomes (1)

  • conversion rate of latent tuberculosis infection in hospital workers

    3months

Study Arms (1)

Health care workers

health care workers who performed TST or Quantiferon-TB Gold In tube assay before

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

health care workers who performed TST or Quantiferon-TB Gold In tube assay before

You may qualify if:

  • age 20-75, men and women
  • participant who was enrolled in the study of latent tuberculosis in health care worker (IRB No.4-2009-0187)
  • high risk or low risk health care worker who was performed TST or Quantiferon-TB Gold In tube assay before

You may not qualify if:

  • age \< 20
  • person who don't agree with enrollment
  • illiterate
  • person who is diagnosed as active tuberculosis now
  • person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
  • pregnant woman
  • person who is treated as active tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital

Seoul, 120-752, South Korea

Location

Related Publications (4)

  • Menzies D, Fanning A, Yuan L, Fitzgerald M. Tuberculosis among health care workers. N Engl J Med. 1995 Jan 12;332(2):92-8. doi: 10.1056/NEJM199501123320206. No abstract available.

    PMID: 7990907BACKGROUND
  • Jiamjarasrangsi W, Hirunsuthikul N, Kamolratanakul P. Tuberculosis among health care workers at King Chulalongkorn Memorial Hospital, 1988-2002. Int J Tuberc Lung Dis. 2005 Nov;9(11):1253-8.

    PMID: 16333934BACKGROUND
  • Schwartzman K, Loo V, Pasztor J, Menzies D. Tuberculosis infection among health care workers in Montreal. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):1006-12. doi: 10.1164/ajrccm.154.4.8887599.

    PMID: 8887599BACKGROUND
  • Kruuner A, Danilovitsh M, Pehme L, Laisaar T, Hoffner SE, Katila ML. Tuberculosis as an occupational hazard for health care workers in Estonia. Int J Tuberc Lung Dis. 2001 Feb;5(2):170-6.

    PMID: 11258511BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood for perfoming Quantiferon-TB Gold in tube assay

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2011

First Posted

June 20, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations