QuantiFERON Change During Anti-tuberculosis Medication | NCT01038830

Studies
QuantiFERON Change During Anti-tuberculosis Medication

NCT01038830

Sponsor

Armed Forces Capital Hospital, Republic of Korea

Status

Completed

Last Update Posted

Jun 14, 2010Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Tuberculosis
Interferon-gamma Release Assay

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

Dec 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

May 2008

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Dec 23, 2009

First Submission Date that Met QC Criteria

Dec 23, 2009

First Posted Date

Dec 24, 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

Jun 11, 2010

Last Update Posted Date

Jun 14, 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 aim of this study is to evaluate the change of QuantiFERON-TB gold in tube assay (QFT) during the treatment of active tuberculosis.

Detailed Description

Patients with active pulmonary tuberculosis are enrolled and, QFTs are performed for each subjects before treatment and 1, 3, 6 months after treatment. Investigators check the level of interferon-gamma, and reversion and conversion of this test.

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

50Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All subjects with active tuberculosis

Exclusion Criteria:

Subjects who cannot complete study
Subjects who have taken anti-tuberculosis medication for more than a month before visit of our hospital

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Young healthy subjects in Korean military

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

Condition Browse Module

MeSH Terms

ID	Term
D014376	Tuberculosis

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided