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Development of Tuberculosis Diagnostic Kit

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2006 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00311207
First Posted: April 5, 2006
Last Update Posted: April 5, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Taichung Veterans General Hospital
  Purpose

Pulmonary tuberculosis is one of the most important infectious diseases in human with high mortality.

Early diagnosis followed by antibiotic treatment is the only way for control of the disease. However, most of commercial tuberculosis diagnostic kits are of moderate sensitivity. Oncoprobe Inc. recently developed a tuberculosis diagnostic kit (HR-103) based on detection of antibody against Mycobacterium tuberculosis in serum. The main purpose of this project is to evaluate the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine, pleura and serum samples.Capilia TB assay and another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be tried to detection tuberculous disease.


Condition Phase
Tuberculosis Lung Cancer Pneumonia Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Development of Tuberculosis Diagnostic Kit

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Estimated Enrollment: 200
Study Start Date: December 2005
Estimated Study Completion Date: November 2006
Detailed Description:

Sputum samples from 200 patients with chest or respiratory problems will be collected. Presence of M.

tuberculosis in the samples will be checked by acid-fast stain and bacterial culture and identification methods.

At the same time, saliva, urine, and serum samples from these 200 patients and 50 healthy volunteers will be collected. The tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. or capilia TB assay or another Immunochromatographic assay such as ESAT-6 and CFP-10 based or other PCR based immunochromatographic assay will be used to detect tuberculosis disease from these samples. By comparing the results with the stain and identification results of sputum samples from the 200 patients, the sensitivity and specificity of the kit in detection of pulmonary tuberculosis from saliva, urine,pleura and serum samples, as well as from combination of these samples, will be obtained. In addition to pulmonary tuberculosis, M. tuberculosis causes pleural tuberculosis. Diagnosis of pleural tuberculosis involves determination of activities of adenosine deaminase and interferon-gamma in pleural effusion, which is tedious. We also plan to collect pleural effusion samples from 100 patients, and examined by the tuberculosis diagnostic kit (HR-103) from Oncoprobe Inc. By comparing the results with the adenosine deaminase and interferon-gamma activities of the same samples, the sensitivity and specificity of the kit in detection of pleural tuberculosis from pleural effusion samples will be obtained.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: clinical suspicious of tuberculosis

Exclusion Criteria:

  • HIV
  Contacts and Locations
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): NCT00311207


Contacts
Contact: Shen Gwan Han, MD 886-4-23592525 ext 3217 911B@vghtc.gov.tw

Locations
Taiwan
Taichung Veterans General Hospital Recruiting
Taichung, Taiwan, 407
Contact: Shen Gwan Han, MD    886-4-23592525 ext 3217    911B@vghtc.gov.tw   
Principal Investigator: Shen Gwan Han, MD         
Sponsors and Collaborators
Taichung Veterans General Hospital
Investigators
Principal Investigator: Shen Gwan Han, MD Respiratory and Critical care medicine department of Taichung Veterans General Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00311207     History of Changes
Other Study ID Numbers: 940601/C05098
First Submitted: March 24, 2006
First Posted: April 5, 2006
Last Update Posted: April 5, 2006
Last Verified: April 2006

Keywords provided by Taichung Veterans General Hospital:
diagnostic kit
immunochromatography test
PCR detection kit
luminex

Additional relevant MeSH terms:
Pneumonia
Tuberculosis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections