Healthcare Associated Pneumonia Clinical Trial
Official title:
Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
| NCT number | NCT01966796 |
| Other study ID # | 102013-E |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 2013 |
| Est. completion date | October 2013 |
| Verified date | September 2020 |
| Source | Far Eastern Memorial Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 530 |
| Est. completion date | October 2013 |
| Est. primary completion date | October 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: - |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Far Eastern Memorial Hospital | New Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Far Eastern Memorial Hospital |
Taiwan,
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. — View Citation
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. Epub 2000 Sep 7. — View 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. Review. — View 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):390-5. doi: 10.1097/MD.0b013e318239cf0a. — View 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. Epub 2007 Dec 26. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants | sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission | 7 days | |
| Primary | Number of Participants With MDR Pathogens | MDR bacteria were defined as Pseudomonas aeruginosa (P. aeruginosa), Enterobacter species, those not sensitive to second and third generation cephalosporins, Acinetobacter species, extended-spectrum ß-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 |