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

NCT ID: NCT00942916

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Nontuberculous Mycobacterial Pulmonary Infection

Keywords

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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chin-Chung Shu, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital, Yun-Lin Branch

Yun-Lin County, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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200903008R

Identifier Type: -

Identifier Source: org_study_id