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

Mycobacterium Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00999076
• Other study ID #: 2009-09-004
• Status: Terminated
• Phase: N/A
• First received: October 20, 2009
• Last updated: December 17, 2012
• Start date: September 2009
• Est. completion date: December 2011

Study information

• Verified date: December 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients with AFB-smear positive sputum

Exclusion Criteria:

• Non-applicable

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atypical Mycobacteria
• Mycobacterium Infections

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Results of REBA for identification of NTM species		End of study	No