Serum Inflammatory Marker in Patients With Diagnosis of Nontuberculous Mycobacterial Pulmonary Infection
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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 |
- Diagnosis of NTM pulmonary disease according to the ATS guidelines [ Time Frame: 2 year ] [ Designated as safety issue: No ]
- 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 |
The patient was diagnosed as NTM pulmonary disease. They had satisfied at least microbiological, radiographical and clinical 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| Taiwan | |
| National Taiwan University Hospital, Yun-Lin Branch | |
| Yun-Lin County, Taiwan, 640 | |
| 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 June 18, 2013