Microbiology and Clinical Outcome of Pneumonia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by Taichung Veterans General Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Merck Sharp & Dohme Corp.
Information provided by:
Taichung Veterans General Hospital
ClinicalTrials.gov Identifier:
NCT00873522
First received: March 31, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose
  1. 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.

  2. 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

  3. 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

Resource links provided by NLM:


Further study details as provided by Taichung Veterans General Hospital:

Primary Outcome Measures:
  • 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
Study Population

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)
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00873522

Contacts
Contact: Chieh-Liang Wu, MD +886-4-23592525 ext 3370 clwu@vghtc.gov.tw

Locations
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         
Sponsors and Collaborators
Taichung Veterans General Hospital
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Merck Sharp & Dohme Corp.
Investigators
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 July 28, 2014