NCT00942916

Brief Summary

This study is for those who had nontuberculous mycobacterial pulmonary infection with higher a serum inflammatory marker than those who had colonization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 30, 2012

Status Verified

June 1, 2012

Enrollment Period

2 years

First QC Date

July 19, 2009

Last Update Submit

August 28, 2012

Conditions

Nontuberculous Mycobacterial Pulmonary Infection

Keywords

Make sure the difference of the serum inflammatory marker between the two groups

Outcome Measures

Primary Outcomes (1)

  • Diagnosis of NTM pulmonary disease according to the ATS guidelines

    2 year

Secondary Outcomes (1)

  • mortality

    2 year

Study Arms (2)

Patients with confirmed diagnosis of NTM pulmonary disease

Those with sputum mycobacterial culture yielded the same NTM species for at least two sets within one year.

Patients with not definite NTM pulmonary disease

Those who had sputum culture yielded NTM but did not satisfy the criteria for diagnosis with NTM pulmonary disease.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patient was diagnosed as NTM pulmonary disease. They had satisfied at least microbiological, radiographical and clinical criteria.

You may qualify if:

  • more than 18 years
  • study group : Satisfied the criteria for NTM pulmonary disease according to the ATS diagnosis guidelines.
  • control groups: they had positive sputum culture for NTM but not fulfilled the diagnosis criteria

You may not qualify if:

  • Those with bleeding tendency
  • No inform consent
  • Female with pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, 640, Taiwan

Location

Study Officials

  • Chin-Chung Shu, MD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2009

First Posted

July 21, 2009

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 30, 2012

Record last verified: 2012-06

Locations

TW(1)