Clinical trial NCT01966796: Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
Official title: Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthcare Associated Pneumonia
Keywords: healthcare associated pneumonia
drug-resistant bacteria
pneumonia severity index
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who were admitted to the Far Eastern Memorial Hospital, an 800-bed tertiary care hospital in northern Taiwan, from January 2005 to December 2010 were screened by discharge diagnoses.The patients whose primary discharge diagnosis was pneumonia (International Classification of Diseases codes 482, 485, and 486) were selected.

Brief summary: 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.

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
timeFrame: 7 days
measure: Number of Participants With MDR Pathogens
timeFrame: seven days after admission
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Ping-huai Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.