Microbiology and Clinical Outcome of Pneumonia

NCT00873522 | Unknown

• 1 other identifier: C08012
• Study Type: observational
• Target: 2,600
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.BACKGROUND
2. 2.Objectives:
3. 3.Study design:

Conditions

Pneumonia

Keywords

pneumonia

Outcome Measures

Primary Outcomes (1)

• Success/favorable clinical response after treatment for pneumonia

  weeks

Study Arms (2)

Community acquired pneumonia

Health-Care-Associated pneumonia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead
• National Taiwan University Hospital: collaborator
• Taipei Veterans General Hospital, Taiwan: collaborator
• Chang Gung Memorial Hospital: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chieh-Liang Wu, MD

  Department of Respiratory Therapy, Taichung Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-Liang Wu, MD

CONTACT

+886-4-23592525; clwu@vghtc.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 1, 2009
• Study Start: March 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 1, 2009

Record last verified: 2009-03

Locations

TW (1)