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Diagnosis of Active Tuberculosis by ELISPOT

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ClinicalTrials.gov Identifier: NCT00174083
Recruitment Status : Unknown
Verified July 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : September 15, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
Recent studies revealed that the ex vivo enzyme-linked immunospot (ELISPOT) assay for gamma interferon is a specific method for contact tracing of Mycobacterium tuberculosis infection. However, its use in endemic area and bacillus Calmette-Guérin (BCG)-vaccinated hosts has not been proved. We hypothesize that the TB-ELISPOT assay can be a rapid and accurate diagnostic tool for active tuberculosis in clinical suspects in Taiwan.

Condition or disease
Tuberculosis

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Diagnosis of Active Tuberculosis in Endemic Area by Using Enzyme-Linked Immunospot Assay for Gamma-Interferon
Study Start Date : August 2005
Estimated Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
Drug Information available for: Interferon
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who present with fever or respiratory symptoms (cough, dyspnea, or hemoptysis) lasting for ≥ 2 weeks and have compatible radiographic findings were considered clinical suspects of TB.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00174083


Contacts
Contact: Jann-Yuan Wang, MD 886-2-23562905 jywang@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Jann-Yuan Wang, MD    886-2-23562905    jywang@ntu.edu.tw   
Contact: Li-Na Lee, PhD    886-2-23563905    linalee@ntu.edu.tw   
Principal Investigator: Jann-Yuan Wang, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jann-Yuan Wang, MD physician

Publications:

ClinicalTrials.gov Identifier: NCT00174083     History of Changes
Other Study ID Numbers: 9461700717
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: September 15, 2005
Last Verified: July 2005

Keywords provided by National Taiwan University Hospital:
Tuberculosis, TB-ELISPOT, active tuberculosis latent infection interferon

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents