- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174083
Diagnosis of Active Tuberculosis by ELISPOT
September 13, 2005 updated by: National Taiwan University Hospital
Diagnosis of Active Tuberculosis in Endemic Area by Using Enzyme-Linked Immunospot Assay for Gamma-Interferon
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment
200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan
- Recruiting
- National Taiwan University Hospital
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Contact:
- Jann-Yuan Wang, MD
- Phone Number: 886-2-23562905
- Email: jywang@ntu.edu.tw
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Contact:
- Li-Na Lee, PhD
- Phone Number: 886-2-23563905
- Email: linalee@ntu.edu.tw
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Principal Investigator:
- Jann-Yuan Wang, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jann-Yuan Wang, MD, Physician
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Torres M, Herrera T, Villareal H, Rich EA, Sada E. Cytokine profiles for peripheral blood lymphocytes from patients with active pulmonary tuberculosis and healthy household contacts in response to the 30-kilodalton antigen of Mycobacterium tuberculosis. Infect Immun. 1998 Jan;66(1):176-80. doi: 10.1128/IAI.66.1.176-180.1998.
- Wilkinson RJ, Vordermeier HM, Wilkinson KA, Sjolund A, Moreno C, Pasvol G, Ivanyi J. Peptide-specific T cell response to Mycobacterium tuberculosis: clinical spectrum, compartmentalization, and effect of chemotherapy. J Infect Dis. 1998 Sep;178(3):760-8. doi: 10.1086/515336.
- Wilkinson KA, Wilkinson RJ, Pathan A, Ewer K, Prakash M, Klenerman P, Maskell N, Davies R, Pasvol G, Lalvani A. Ex vivo characterization of early secretory antigenic target 6-specific T cells at sites of active disease in pleural tuberculosis. Clin Infect Dis. 2005 Jan 1;40(1):184-7. doi: 10.1086/426139. Epub 2004 Dec 8.
- Ulrichs T, Munk ME, Mollenkopf H, Behr-Perst S, Colangeli R, Gennaro ML, Kaufmann SH. Differential T cell responses to Mycobacterium tuberculosis ESAT6 in tuberculosis patients and healthy donors. Eur J Immunol. 1998 Dec;28(12):3949-58. doi: 10.1002/(SICI)1521-4141(199812)28:123.0.CO;2-4. Erratum In: Eur J Immunol 1999 Feb;29(2):725.
- Ulrichs T, Anding R, Kaufmann SH, Munk ME. Numbers of IFN-gamma-producing cells against ESAT-6 increase in tuberculosis patients during chemotherapy. Int J Tuberc Lung Dis. 2000 Dec;4(12):1181-3.
- Skjot RL, Oettinger T, Rosenkrands I, Ravn P, Brock I, Jacobsen S, Andersen P. Comparative evaluation of low-molecular-mass proteins from Mycobacterium tuberculosis identifies members of the ESAT-6 family as immunodominant T-cell antigens. Infect Immun. 2000 Jan;68(1):214-20. doi: 10.1128/IAI.68.1.214-220.2000.
- Schluger NW, Rom WN. The host immune response to tuberculosis. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):679-91. doi: 10.1164/ajrccm.157.3.9708002. No abstract available.
- Richeldi L, Ewer K, Losi M, Bergamini BM, Roversi P, Deeks J, Fabbri LM, Lalvani A. T cell-based tracking of multidrug resistant tuberculosis infection after brief exposure. Am J Respir Crit Care Med. 2004 Aug 1;170(3):288-95. doi: 10.1164/rccm.200403-307OC. Epub 2004 May 6.
- Ravn P, Demissie A, Eguale T, Wondwosson H, Lein D, Amoudy HA, Mustafa AS, Jensen AK, Holm A, Rosenkrands I, Oftung F, Olobo J, von Reyn F, Andersen P. Human T cell responses to the ESAT-6 antigen from Mycobacterium tuberculosis. J Infect Dis. 1999 Mar;179(3):637-45. doi: 10.1086/314640.
- Pollock JM, Andersen P. The potential of the ESAT-6 antigen secreted by virulent mycobacteria for specific diagnosis of tuberculosis. J Infect Dis. 1997 May;175(5):1251-4. doi: 10.1086/593686.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2005
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
September 15, 2005
Last Update Submitted That Met QC Criteria
September 13, 2005
Last Verified
July 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9461700717
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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