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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00999076
First Posted: October 21, 2009
Last Update Posted: December 18, 2012
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 (Responsible Party):
Won-Jung Koh, Samsung Medical Center
  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:


Further study details as provided by Won-Jung Koh, Samsung Medical Center:

Primary Outcome Measures:
  • Results of REBA for identification of NTM species [ Time Frame: End of study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Won-Jung Koh, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00999076     History of Changes
Other Study ID Numbers: 2009-09-004
First Submitted: October 20, 2009
First Posted: October 21, 2009
Last Update Posted: December 18, 2012
Last Verified: December 2012

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