Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

• Sponsor: Far Eastern Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01966796
• Collaborator: (none)
• Enrollment: 530
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 66.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthcare Associated Pneumonia

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 Design

• Study Type: Observational
• Actual Enrollment: 530 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia
• Study Start Date: Feb 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Actual Study Completion Date: Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
PSI II PSI less than 70 or equal to 70
PSI III PSI 70-90
PSI IV PSI 90-130
PSI V PSI more than 130

Outcome Measures

Primary Outcome Measures

1. Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants [7 days]

   sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission

2. Number of Participants With MDR Pathogens [seven days after admission]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Far Eastern Memorial Hospital	New Taipei		Taiwan	220

Sponsors and Collaborators

• Far Eastern Memorial Hospital

Investigators

• Principal Investigator: Ping-huai Wang, M.D., Far Eastern Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

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.
• 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.
• 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.
• 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. Epub 2007 Dec 26.

• Responsible Party: Ping-Huai Wang, Medical Dr, Far Eastern Memorial Hospital
• ClinicalTrials.gov Identifier: NCT01966796
• Other Study ID Numbers: 102013-E
• First Posted: Oct 22, 2013
• Last Update Posted: Sep 9, 2020
• Last Verified: Sep 1, 2020

• Keywords provided by Ping-Huai Wang, Medical Dr, Far Eastern Memorial Hospital: healthcare associated pneumonia; drug-resistant bacteria; pneumonia severity index
• Additional relevant MeSH terms: Pneumonia; Healthcare-Associated Pneumonia

Study Results

Participant Flow

Recruitment Details	Patients who were admitted to our hospital,Jan 2005 to Dec 2010 The patients with the diagnosis was pneumonia were selected. They were enrolled if they fulfilled the criteria for HCAP defined in 2005 ATS/IDSA

Arm/Group Title	PSI II	PSI III	PSI IV	PSI V
Arm/Group Description	Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)	Pneumonia severity index 70-90	Pneumonia severity index 91-130	Pneumonia severity index more than 130
Period Title: Overall Study
STARTED	15	51	195	269
COMPLETED	15	51	195	269
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	PSI II	PSI III	PSI IV	PSI V	Total
Arm/Group Description	PSI less than 70 or equal to 70	PSI 70-90	PSI 90-130	PSI more than 130	Total of all reporting groups
Overall Participants	15	51	195	269	530
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	12 80%	21 41.2%	50 25.6%	17 6.3%	100 18.9%
>=65 years	3 20%	30 58.8%	145 74.4%	252 93.7%	430 81.1%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.7 (12.5)	66.4 (11.7)	73.3 (12.5)	79.5 (10.2)	75.1 (12.8)
Sex: Female, Male (Count of Participants)
Female	5 33.3%	20 39.2%	56 28.7%	100 37.2%	181 34.2%
Male	10 66.7%	31 60.8%	139 71.3%	169 62.8%	349 65.8%
Region of Enrollment (participants) [Number]
Taiwan	15 100%	51 100%	195 100%	269 100%	530 100%

Outcome Measures

1. Primary Outcome

Title	Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
Description	sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
Time Frame	7 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PSI II	PSI III	PSI IV	PSI V
Arm/Group Description	Pneumonia severity index less than 70 or equal to 70, (Pneumonia is more severe if the index is higher)	Pneumonia severity index 70-90	Pneumonia severity index 91-130	Pneumonia severity index more than 130
Measure Participants	15	51	195	269
Count of Participants [Participants]	15 100%	51 100%	195 100%	269 100%

2. Primary Outcome

Title	Number of Participants With MDR Pathogens
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).
Time Frame	seven days after admission

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PSI II	PSI III	PSI IV	PSI V
Arm/Group Description	PSI less than 70 or equal to 70	PSI 70-90	PSI 90-130	PSI more than 130
Measure Participants	15	51	195	269
MDR	1 6.7%	13 25.5%	72 36.9%	120 44.6%
mortality	0 0%	3 5.9%	24 12.3%	64 23.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	PSI II, PSI III, PSI IV, PSI V
	Comments	The incidence of MDR pathogens (6.7%, 25.5%, 36.9% and 44.6% in PSI II, III, IV, and V, respectively, p=0.002) and mortality rate (0, 5.9%, 12.3%, and 23.8%, respectively, p<0.001) increased with increasing PSI
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANOVA
	Comments

Adverse Events

Adverse Event Reporting Description	It was a retrospective observational study. No intervention was done during this study. Thereafter, no serious adverse event was assessed.
Arm/Group Title	PSI II		PSI III		PSI IV		PSI V
Arm/Group Description	PSI less than 70 or equal to 70		PSI 70-90		PSI 90-130		PSI more than 130
All Cause Mortality
	PSI II		PSI III		PSI IV		PSI V
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	PSI II		PSI III		PSI IV		PSI V
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Investigations
Serious adverse event	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	PSI II		PSI III		PSI IV		PSI V
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Investigations
non-serious adverse event	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

The limitations to this study is that the microbiology data mainly came from sputum cultures, retrospective studies and single center experience

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.