Development of Tuberculosis Diagnostic Kit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2006 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00311207
First received: March 24, 2006
Last updated: April 3, 2006
Last verified: April 2006
  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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: clinical suspicious of tuberculosis

-

Exclusion Criteria:

  • HIV
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00311207     History of Changes
Other Study ID Numbers: 940601/C05098
Study First Received: March 24, 2006
Last Updated: April 3, 2006
Health Authority: Taiwan: Department of Health

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

Additional relevant MeSH terms:
Tuberculosis
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections

ClinicalTrials.gov processed this record on October 29, 2014