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Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00942916
First Posted: July 21, 2009
Last Update Posted: August 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Taiwan University Hospital
  Purpose
This study is for those who had nontuberculous mycobacterial pulmonary infection with higher a serum inflammatory marker than those who had colonization.

Condition
Nontuberculous Mycobacterial Pulmonary Infection

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Diagnosis of NTM pulmonary disease according to the ATS guidelines [ Time Frame: 2 year ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 year ]

Enrollment: 50
Study Start Date: June 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:
Nontuberculous mycobacteria (NTM), not like Mycobacterium tuberculosis, is ubiquitous in environment including soil and water. Therefore, NTM pulmonary infection is not diagnosed only by microbiology of respiratory specimen but also clinical and radiographical findings.(1) Due to airway NTM colonization is not uncommon in sputum, diagnosis of pulmonary NTM infection is a big challenge in clinical practice. Especially NTM burden is increasing in recent literature.(2,3) Besides, the short-term mortality is reported higher in patients with NTM infection in medical ICU by Shu et al.(4) Early diagnosis and then treatment of NTM infection become important though NTM infection is considered as indolent process before.(1) Inflammatory marker in the patients with NTM being isolated from respiratory specimens is an indicator for differentiating true infection from colonization.(5,6) Those inflammatory factors might include blood white count, C-reactive protein, cytokines, procalcitonin , trigger receptor expressed on myeloid cell-1 (TREM-1) and Toll-like receptor-2. We therefore conduct this prospective study for analyzing
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patient was diagnosed as NTM pulmonary disease. They had satisfied at least microbiological, radiographical and clinical criteria.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those with bleeding tendency
  • No inform consent
  • Female with pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00942916


Locations
Taiwan
National Taiwan University Hospital, Yun-Lin Branch
Yun-Lin County, Taiwan, 640
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Chin-Chung Shu, MD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00942916     History of Changes
Other Study ID Numbers: 200903008R
First Submitted: July 19, 2009
First Posted: July 21, 2009
Last Update Posted: August 30, 2012
Last Verified: June 2012

Keywords provided by National Taiwan University Hospital:
Make sure the difference of the serum inflammatory marker between the two groups

Additional relevant MeSH terms:
Infection
Communicable Diseases