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

Nontuberculous Mycobacterial Pulmonary Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00942916
• Other study ID #: 200903008R
• Status: Completed
• Phase: N/A
• First received: July 19, 2009
• Last updated: August 28, 2012
• Start date: June 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infection
• Nontuberculous Mycobacterial Pulmonary Infection

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital, Yun-Lin Branch	Yun-Lin County

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of NTM pulmonary disease according to the ATS guidelines		2 year	No
Secondary	mortality		2 year	No