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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00999076
First received: October 20, 2009
Last updated: December 17, 2012
Last verified: December 2012
History of Changes
  Purpose

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
Atypical Mycobacteria
Mycobacterium Infections

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rapid Identification of Mycobacteria in Acid-fast Bacilli Smear-positive Respiratory Specimens

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Results of REBA for identification of NTM species [ Time Frame: End of study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Sputum with positive AFB smear


Enrollment: 200
Study Start Date: September 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sputum with positive AFB smear

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with AFB-smear positive sputum

Criteria

Inclusion Criteria:

  • Patients with AFB-smear positive sputum

Exclusion Criteria:

  • Non-applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999076

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: Won-Jung Koh, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00999076     History of Changes
Other Study ID Numbers: 2009-09-004
Study First Received: October 20, 2009
Last Updated: December 17, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 19, 2013