The Clinical Utility of QuantiFERON in the Diagnosis of A... | NCT00982969

Studies
The Clinical Utility of QuantiFERON in the Diagnosis of Active Tuberculosis

NCT00982969

Sponsor

Armed Forces Capital Hospital, Republic of Korea

Status

Completed

Last Update Posted

Jul 20, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Tuberculosis

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Oct 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 22, 2009

First Submission Date that Met QC Criteria

Sep 22, 2009

First Posted Date

Sep 23, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2010

Last Update Posted Date

Jul 20, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators will evaluate the usefulness of QuantiFERON-TB Gold in-tube (QFT) in the diagnosis of active tuberculosis in young adults group, highly clinically suspected tuberculosis.

Detailed Description

Investigators will enroll prospectively all clinically and radiologically suspected tuberculosis patients from 20 to 29 years old who visited the Armed Forces Capital Hospital. Investigators will perform QFT and tuberculin skin test. Diagnosis of tuberculosis will be made by World Health Organization guideline and the physician will not know the QuantiFERON-TB Gold in-tube results before the diagnosis and anti-tuberculosis medication. Investigators will evaluate the sensitivity and specificity of QuantiFERON-TB Gold in-tube in the diagnosis of active tuberculosis among young adults.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
TB suspected		Soldiers who are clinically suspected with tuberculosis

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All clinically and radiologically suspected TB patients from 20 to 29 years old who visited the Armed Forces Capital Hospital

Exclusion Criteria:

Soldiers who do not agree with study protocol

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Soldiers in South Korean Army

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Armed Forces Capital Hospital		Seongnam-si	Gyeonggi-do	463-040	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21501477	Derived	Lee JE, Kim HJ, Lee SW. The clinical utility of tuberculin skin test and interferon-gamma release assay in the diagnosis of active tuberculosis among young adults: a prospective observational study. BMC Infect Dis. 2011 Apr 18;11:96. doi: 10.1186/1471-2334-11-96.

ID	Term
D014376	Tuberculosis
D011014	Pneumonia

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections