Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens

Sponsor
Samsung Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT00999076
Collaborator
(none)
200
1
27
7.4

Study Details

Study Description

Brief Summary

The aim of the study is to evaluate the polymerase chain reaction (PCR)-Reverse Blot Hybridization Assay (REBA) for identification of nontuberculous mycobacteria (NTM) species in acid-fast bacilli (AFB) smear-positive respiratory specimens.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens
    Study Start Date :
    Sep 1, 2009
    Actual Primary Completion Date :
    Dec 1, 2011
    Actual Study Completion Date :
    Dec 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Sputum with positive AFB smear

    Outcome Measures

    Primary Outcome Measures

    1. Results of REBA for identification of NTM species [End of study]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with AFB-smear positive sputum
    Exclusion Criteria:
    • Non-applicable

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Samsung Medical Center Seoul Korea, Republic of 135-710

    Sponsors and Collaborators

    • Samsung Medical Center

    Investigators

    • Principal Investigator: Won-Jung Koh, M.D., Samsung Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won-Jung Koh, Associate Professor, Samsung Medical Center
    ClinicalTrials.gov Identifier:
    NCT00999076
    Other Study ID Numbers:
    • 2009-09-004
    First Posted:
    Oct 21, 2009
    Last Update Posted:
    Dec 18, 2012
    Last Verified:
    Dec 1, 2012
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 18, 2012