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Diagnosis of Active Tuberculosis by ELISPOT

NCT ID: NCT00174083

Last Updated: 2005-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tuberculosis

Keywords

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Tuberculosis, TB-ELISPOT, active tuberculosis latent infection interferon

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Jann-Yuan Wang, MD

Role: PRINCIPAL_INVESTIGATOR

physician

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jann-Yuan Wang, MD

Role: CONTACT

Phone: 886-2-23562905

Email: [email protected]

Facility Contacts

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Jann-Yuan Wang, MD

Role: primary

Li-Na Lee, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 9728545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15614710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9862331 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11144463 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9423855 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10603390 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9517576 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15130907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9952370 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9129098 (View on PubMed)

Other Identifiers

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9461700717

Identifier Type: -

Identifier Source: org_study_id