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Exogenous Reinfection of Tuberculosis in Taiwan

Primary Purpose

Tuberculosis

Status
Completed
Phase
Locations
Taiwan
Study Type
Observational
Intervention
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Tuberculosis focused on measuring tuberculosis, relapse, reinfection, reactivation, dormancy, tuberculin skin test

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: culture-proven tuberculosis with recurrence

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Arm Label

Culture-confirmed relapse of TB

Arm Description

Patients who have a recurrent episode of culture-confirmed TB after completion of treatment for the first episode of culture-confirmed TB

Outcomes

Primary Outcome Measures

relapse due to reinfection
proportion of patients with exogenous reinfection in those with relapse of TB

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
December 8, 2014
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00173433
Brief Title
Exogenous Reinfection of Tuberculosis in Taiwan
Official Title
The Importance of Exogenous Reinfection in the Tuberculosis Endemic of Taiwan
Study Type
Observational

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

5. Study Description

Brief Summary
we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.
Detailed Description
Tuberculosis (TB) remains the most important infectious disease in the world. In Taiwan, the incidence of TB increased in recent years. The failure of control implies the necessity to reevaluate the epidemiology of Mycobacterium tuberculosis. It is widely thought that most cases of TB are caused by reactivation of a latent infection. Treatment programs have therefore focused on cure rates rather than tracking of additional cases. But recent studies showed that exogenous reinfection plays an important role in the development of TB. In addition, it seems that the higher the local incidence, the more important exogenous reinfection is. The question of exogenous reinfection versus endogenous reactivation has an impact on the distribution of resources for the prevention and treatment of TB. Based on these evidences, we hypothesize that exogenous reinfection is very important in the Taiwan endemic. Therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the Taiwan endemic, and to realize the impact of exogenous reinfection. First, we will identify the patients with TB relapse after complete treatment. The M. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis
Keywords
tuberculosis, relapse, reinfection, reactivation, dormancy, tuberculin skin test

7. Study Design

Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Culture-confirmed relapse of TB
Arm Description
Patients who have a recurrent episode of culture-confirmed TB after completion of treatment for the first episode of culture-confirmed TB
Primary Outcome Measure Information:
Title
relapse due to reinfection
Description
proportion of patients with exogenous reinfection in those with relapse of TB
Time Frame
6 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: culture-proven tuberculosis with recurrence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jann-Yuan Wang, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

Citations:
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Exogenous Reinfection of Tuberculosis in Taiwan

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