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

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

Study Overview

• Status: Completed
• Conditions: 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

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Taiwan
  • Yun-Lin County, Taiwan, 640
    • National Taiwan University Hospital, Yun-Lin branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patient was diagnosed as NTM pulmonary disease. They had satisfied at least microbiological, radiographical and clinical criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Diagnosis of NTM pulmonary disease according to the ATS guidelines	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
mortality	2 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Chin-Chung Shu, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: July 19, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 21, 2009

Study Record Updates

• Last Update Posted (Estimate): August 30, 2012
• Last Update Submitted That Met QC Criteria: August 28, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Make sure the difference of the serum inflammatory marker between the two groups
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 200903008R