- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966796
Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
Background The prediction of multi-drug resistant (MDR) pathogens is a key issue in the management of health-care associated pneumonia (HCAP). Multiple risk factors have been proposed, some of which overlap with items of the pneumonia severity index (PSI). The aim of this study was to investigate the relationship between PSI and presence of MDR pathogens.
Methods Patients who were admitted to a tertiary-care hospital from January 2005 to December 2010 were screened by a discharge diagnosis of pneumonia. Patients were enrolled if they fulfilled the definition of HCAP by 2005 ATS/IDSA guideline.
Study Overview
Status
Conditions
Detailed Description
MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E. coli) and Klebsiella pneumoniae (K. pneumoniae), Burkholderia cepacia (B. cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
The criteria for HCAP is defined as follows: patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days; residents of a nursing home or long-term care facility; recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days; or patients who attended a hospital or hemodialysis clinic.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who had been hospitalized in an acute care hospital for two or more days within the past 90 days;
- residents of a nursing home or long-term care facility;
- recipients of recent intravenous antibiotic therapy, chemotherapy or wound care within the past 30 days;
- or patients who attended a hospital or hemodialysis clinic.
Exclusion Criteria:
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Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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PSI II
PSI less than 70 or equal to 70
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PSI III
PSI 70-90
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PSI IV
PSI 90-130
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PSI V
PSI more than 130
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
Time Frame: 7 days
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sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
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7 days
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Number of Participants With MDR Pathogens
Time Frame: seven days after admission
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MDR bacteria were defined as Pseudomonas aeruginosa (P.
aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum β-lactamase (ESBL) Enterobacteriaceae such as Escherichia coli (E.
coli) and Klebsiella pneumoniae (K.
pneumoniae), Burkholderia cepacia (B.
cepacia), Stenotrophomonas maltophilia (S. maltophilia), and methicillin resistant Staphylococcus aureus (MRSA).
|
seven days after admission
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ping-huai Wang, M.D., Far Eastern Memorial Hospital
Publications and helpful links
General Publications
- American Thoracic Society; Infectious Diseases Society of America. Guidelines for the management of adults with hospital-acquired, ventilator-associated, and healthcare-associated pneumonia. Am J Respir Crit Care Med. 2005 Feb 15;171(4):388-416. doi: 10.1164/rccm.200405-644ST. No abstract available.
- Bartlett JG, Dowell SF, Mandell LA, File TM Jr, Musher DM, Fine MJ. Practice guidelines for the management of community-acquired pneumonia in adults. Infectious Diseases Society of America. Clin Infect Dis. 2000 Aug;31(2):347-82. doi: 10.1086/313954. Epub 2000 Sep 7. No abstract available.
- Hospital-acquired pneumonia in adults: diagnosis, assessment of severity, initial antimicrobial therapy, and preventive strategies. A consensus statement, American Thoracic Society, November 1995. Am J Respir Crit Care Med. 1996 May;153(5):1711-25. doi: 10.1164/ajrccm.153.5.8630626. No abstract available.
- Micek ST, Reichley RM, Kollef MH. Health care-associated pneumonia (HCAP): empiric antibiotics targeting methicillin-resistant Staphylococcus aureus (MRSA) and Pseudomonas aeruginosa predict optimal outcome. Medicine (Baltimore). 2011 Nov;90(6):390-395. doi: 10.1097/MD.0b013e318239cf0a.
- Song JH, Oh WS, Kang CI, Chung DR, Peck KR, Ko KS, Yeom JS, Kim CK, Kim SW, Chang HH, Kim YS, Jung SI, Tong Z, Wang Q, Huang SG, Liu JW, Lalitha MK, Tan BH, Van PH, Carlos CC, So T; Asian Network for Surveillance of Resistant Pathogens Study Group. Epidemiology and clinical outcomes of community-acquired pneumonia in adult patients in Asian countries: a prospective study by the Asian network for surveillance of resistant pathogens. Int J Antimicrob Agents. 2008 Feb;31(2):107-14. doi: 10.1016/j.ijantimicag.2007.09.014. Epub 2007 Dec 26.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 102013-E
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