NCT00999076

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 18, 2012

Status Verified

December 1, 2012

Enrollment Period

2.2 years

First QC Date

October 20, 2009

Last Update Submit

December 17, 2012

Conditions

Atypical MycobacteriaMycobacterium Infections

Outcome Measures

Primary Outcomes (1)

  • Results of REBA for identification of NTM species

    End of study

Study Arms (1)

Sputum with positive AFB smear

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with AFB-smear positive sputum

You may qualify if:

  • Patients with AFB-smear positive sputum

You may not qualify if:

  • Non-applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sputum with positive AFB smear

MeSH Terms

Conditions

Mycobacterium Infections

Condition Hierarchy (Ancestors)

Actinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Won-Jung Koh, M.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 18, 2012

Record last verified: 2012-12

Locations

KR(1)