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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00942916
First received: July 19, 2009
Last updated: August 28, 2012
Last verified: June 2012
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 2 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00942916     History of Changes
Other Study ID Numbers: 200903008R
Study First Received: July 19, 2009
Last Updated: August 28, 2012
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on July 31, 2014