NCT00962676

Brief Summary

For diagnosis of active tuberculosis, interferon-γ release assay based mycobacterium tuberculosis specific antigen may show higher sensitivity than tuberculin skin test in immunocompromised patients. Therefore, interferon-γ release assay have a role as a rapid diagnostic adjunctive methods for active tuberculosis in immunocompromised patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

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

July 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 20, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

1.4 years

First QC Date

August 19, 2009

Last Update Submit

January 31, 2012

Conditions

Tuberculosis

Keywords

suspicious of tuberculosisimmunocompromised patients

Study Arms (2)

immunocompromised group

non-immunocompromised group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

suspicious of tuberculosis, immunocompromised patients such cancer patients on chemotherapy, transplantation patients, patients with immunosuppressant

You may qualify if:

  • Patient suspicious of active tuberculosis with immunocompromised condition
  • Immunocompromised condition patients with
  • solid cancer with chemotherapy
  • hematologic malignancy
  • organ transplantation
  • immunosuppressant
  • ESRD on renal replacement therapy
  • diabetes
  • advanced liver cirrhosis

You may not qualify if:

  • Patients with
  • less than 20 years
  • who don't agree the participation of study
  • hypersensitivity history to tuberculin
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Univ.

Seoul, South Korea

Location

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2009

First Posted

August 20, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

KR(1)