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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00942916
Collaborator
(none)
50
Enrollment
1
Location
24
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    Study Design

    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 :
    Jun 1, 2009
    Actual Primary Completion Date :
    Jun 1, 2011
    Actual Study Completion Date :
    Jun 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis of NTM pulmonary disease according to the ATS guidelines [2 year]

    Secondary Outcome Measures

    1. mortality [2 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT00942916
    Other Study ID Numbers:
    • 200903008R
    First Posted:
    Jul 21, 2009
    Last Update Posted:
    Aug 30, 2012
    Last Verified:
    Jun 1, 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:
    Infections
    Communicable Diseases

    Study Results

    No Results Posted as of Aug 30, 2012