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
  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 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
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: 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 July 29, 2014