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Microbiology and Clinical Outcome of Pneumonia

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ClinicalTrials.gov Identifier: NCT00873522
Recruitment Status : Unknown
Verified March 2009 by Taichung Veterans General Hospital.
Recruitment status was:  Recruiting
First Posted : April 1, 2009
Last Update Posted : April 1, 2009
Information provided by:

Study Description
Brief Summary:

    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 or disease

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 2600 participants
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
Study Start Date : March 2008
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia
U.S. FDA Resources

Groups and Cohorts

Community acquired pneumonia
Health-Care-Associated pneumonia

Outcome Measures

Primary Outcome Measures :
  1. Success/favorable clinical response after treatment for pneumonia [ Time Frame: weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00873522

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

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.
Principal Investigator: Chieh-Liang Wu, MD Department of Respiratory Therapy, Taichung Veterans General Hospital
More Information

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
First Posted: April 1, 2009    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: March 2009

Keywords provided by Taichung Veterans General Hospital:

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections