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

December 17, 2012 updated by: Won-Jung Koh, Samsung Medical Center
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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with AFB-smear positive sputum

Description

Inclusion Criteria:

  • Patients with AFB-smear positive sputum

Exclusion Criteria:

  • Non-applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sputum with positive AFB smear

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Results of REBA for identification of NTM species
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

October 20, 2009

First Submitted That Met QC Criteria

October 20, 2009

First Posted (Estimate)

October 21, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2012

Last Update Submitted That Met QC Criteria

December 17, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-09-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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