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

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. Identifier: NCT00942916
Recruitment Status : Completed
First Posted : July 21, 2009
Last Update Posted : August 30, 2012
Information provided by (Responsible Party):
National Taiwan University Hospital

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

Condition or disease
Nontuberculous Mycobacterial Pulmonary Infection

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

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection
Study Start Date : June 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

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.

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

Secondary Outcome Measures :
  1. mortality [ Time Frame: 2 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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

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 identifier (NCT number): NCT00942916

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

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Responsible Party: National Taiwan University Hospital Identifier: NCT00942916    
Other Study ID Numbers: 200903008R
First Posted: July 21, 2009    Key Record Dates
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:
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Communicable Diseases