Microbiology and Clinical Outcome of Pneumonia
Recruitment status was Recruiting
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Purpose
BACKGROUND
Pneumonia occurring outside of the hospital setting is regarded as community acquired pneumonia. However, pneumonia occurring in non-hospital long-term care facilities constituted a distinct type of pneumonia from CAP. Kollef et al has justified health care associated pneumonia (HCAP) as a new category of pneumonia [1]. The HCAP patients are associated with severe disease, higher mortality rate, and greater length of stay and increased cost [1]. HCAP are often at risk for multi-drug resistant bacterial pathogens such as Pseudomonas aeruginosa, extended-spectrum beta-lactamase Klebsiella pneumoniae, Acinetobacter baumannii, and methicillin-resistant S. aureus (MRSA) [2].
Health care facilities have not been defined in Taiwan. Respiratory care ward (RCW) is a special unit to take care long-term ventilatory dependent patients in Taiwan. Some of the patients get pneumonia and are referred back to medical centers. Besides, community-acquired P. aeruginosa, Acinetobacter baumannii or MRSA have been reported [3-8]. Therefore, the core-organisms of HCAP in Taiwan might be multi-drug resistant and the causes of inadequate initial antibiotics treatment. The common pathogens were also unknown.
Till now, there are no data about the pathogens of HCAP in Taiwan. We define the health-care facilities and initiate a retrospective study to characterize the microbiology and clinical outcome of Community acquired pneumonia and Health-Care-Associated pneumonia in Taiwan. Further analysis will perform to confirm the differences between CAP an HCAP in Taiwan.
Objectives:
I. To characterize CAP and HCAP i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality , antimicrobial susceptibility and treatment outcomes II. To characterize HCAP from RCW i. Microbiological epidemiology ii. Disease severity: PSI iii. Outcome : length of stay, mortality
- Study design:
This is a retrospective multi-center cohort study to characterize microbiology, and clinical outcomes in Taiwan.
Data sources: CAP or HCAP registered in 4 medical centers from Jan 1 2007 to Dec. 31 2007. (2 in north Taiwan, 1 in central Taiwan, 1 in south Taiwan) Expected case number: 800 HCAP and 1800 CAP
| Condition |
|---|
|
Pneumonia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Microbiology and Clinical Outcome of Community Acquired Pneumonia and Health-Care-Associated Pneumonia in Taiwan: a Multi-Center Study |
- Success/favorable clinical response after treatment for pneumonia [ Time Frame: weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2600 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Community acquired pneumonia |
| Health-Care-Associated pneumonia |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Those adult patients (age ≥ 18 y/o) met the criteria of pneumonia are evaluated. The patients are enrolled if they meet the following criteria [9] .
- The diagnosis of pneumonia is established within 48h of hospitalization (including time of emergency room).
Pneumonia is defined as clinical suspicion of pneumonia (cough, short of breath, expectorant) with new-onset pulmonary infiltrates plus at least one of the following criteria:
- Fever (≥38.3C) or hypothermia (＜36.0C) (axillary temp - 0.5)
- Leukocytosis (increase of total WBC > 10,000/cumm); or leukopenia (<4000/cumm) or band > 10%
- Purulent airway secretion (tracheal aspirates, or sputum)
Inclusion Criteria:
CAP criteria:
- Those pneumonia patients have not been admitted within 14 days before diagnosing pneumonia.
- Those pneumonia patients are not met the criteria of HCAP criteria as stated below.
HCAP criteria:
- Regular hemodialysis, peritoneal dialysis or infusion therapy (ex TPN, repeated blood transfusion etc ) at a hospital or hemodialysis clinic.
- Receive radiation therapy or chemotherapy at out-patient clinics within 90 days
- to be admitted to an acute care hospital for two or more days within 90 days before the onset of pneumonia
- Resided in a nursing home or long-term care
Exclusion Criteria:
- The patients with HAP: pneumonia developed two days after admission or within 14 days after discharge (except RCW)
- VAP: HAP and with mechanical ventilation for at least 48h (except RCW patients)
- HIV positive with a CD4+ < 200
Contacts and Locations| Contact: Chieh-Liang Wu, MD | +886-4-23592525 ext 3370 | clwu@vghtc.gov.tw |
| Taiwan | |
| Taichung Veterans General Hospital | Recruiting |
| Taichung City, Taiwan, 40705 | |
| Contact: Chieh-Liang Wu, MD +886-4-23592525 ext 3370 clwu@vghtc.gov.tw | |
| Principal Investigator: Chieh-Liang Wu, MD | |
| Principal Investigator: | Chieh-Liang Wu, MD | Department of Respiratory Therapy, Taichung Veterans General Hospital |
More Information
No publications provided
| Responsible Party: | Chieh-Liang Wu, Department of Respiratory Therapy, Taichung Veterans General Hospital |
| ClinicalTrials.gov Identifier: | NCT00873522 History of Changes |
| Other Study ID Numbers: | C08012 |
| Study First Received: | March 31, 2009 |
| Last Updated: | March 31, 2009 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Taichung Veterans General Hospital:
|
pneumonia |
Additional relevant MeSH terms:
|
Pneumonia Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013