The Time of Positive Conversion of Interferon-γ Releasing... | NCT00981071

Studies
The Time of Positive Conversion of Interferon-γ Releasing Assay After Tuberculosis Exposure

NCT00981071

Sponsor

Armed Forces Capital Hospital, Republic of Korea

Status

Completed

Last Update Posted

Apr 8, 2010Estimated

Enrollment

32Actual

Phase

Not provided

Conditions

Tuberculosis

Interventions

Not provided

Countries

Not provided

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

Apr 2010

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 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Sep 21, 2009

First Submission Date that Met QC Criteria

Sep 21, 2009

First Posted Date

Sep 22, 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

Apr 7, 2010

Last Update Posted Date

Apr 8, 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 is to evaluate the time of positive conversion after exposure to smear positive pulmonary tuberculosis (TB) in a platoon of Korean military, a closed communal setting.

Detailed Description

In a platoon where TB outbreak occurred, we performed low dose chest CT (LDCT), QuantiFERON-TB gold in tube (QFT) and two-step (0, 4weeks) TST for outbreak investigation. We perform QFT at 0, 2, 4, 8 and 12 weeks after initial investigation for soldiers with negative QFT results, and soldiers with positive QFT and normal LDCT took isoniazid and rifampin for 3 months as treatment of latent TB.

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

32Actual

Label	Type	Description	Intervention Names
A platoon with TB outbreak

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All soldiers who assigned to the military platoon where a tuberculosis outbreak occurred

Exclusion Criteria:

Soldiers who could not complete study or refused the 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

A military unit in South Korean Army

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Joon Yim, MD	Seoul National University Hospital	Principal Investigator

Locations

Not provided

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

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Browse Branches

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