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Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01966796
Enrollment
530
Registered
2013-10-22
Start date
2013-02-28
Completion date
2013-10-31
Last updated
2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthcare Associated Pneumonia

Keywords

healthcare associated pneumonia, drug-resistant bacteria, pneumonia severity index

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.

Interventions

None listed

Sponsors

Far Eastern Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants7 dayssputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
Number of Participants With MDR Pathogensseven days after admissionMDR 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).

Countries

Taiwan

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

Participants by arm

ArmCount
PSI II
PSI less than 70 or equal to 70
15
PSI III
PSI 70-90
51
PSI IV
PSI 90-130
195
PSI V
PSI more than 130
269
Total530

Baseline characteristics

CharacteristicPSI IIIPSI IVPSI IIPSI VTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
30 Participants145 Participants3 Participants252 Participants430 Participants
Age, Categorical
Between 18 and 65 years
21 Participants50 Participants12 Participants17 Participants100 Participants
Age, Continuous66.4 years
STANDARD_DEVIATION 11.7
73.3 years
STANDARD_DEVIATION 12.5
49.7 years
STANDARD_DEVIATION 12.5
79.5 years
STANDARD_DEVIATION 10.2
75.1 years
STANDARD_DEVIATION 12.8
Region of Enrollment
Taiwan
51 participants195 participants15 participants269 participants530 participants
Sex: Female, Male
Female
20 Participants56 Participants5 Participants100 Participants181 Participants
Sex: Female, Male
Male
31 Participants139 Participants10 Participants169 Participants349 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

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 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

ArmMeasureGroupValue (NUMBER)
PSI IINumber of Participants With MDR PathogensMDR1 participants
PSI IINumber of Participants With MDR Pathogensmortality0 participants
PSI IIINumber of Participants With MDR Pathogensmortality3 participants
PSI IIINumber of Participants With MDR PathogensMDR13 participants
PSI IVNumber of Participants With MDR PathogensMDR72 participants
PSI IVNumber of Participants With MDR Pathogensmortality24 participants
PSI VNumber of Participants With MDR PathogensMDR120 participants
PSI VNumber of Participants With MDR Pathogensmortality64 participants
Comparison: 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 PSIp-value: 0.002ANOVA
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

Time frame: 7 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PSI IIPathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants15 Participants
PSI IIIPathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants51 Participants
PSI IVPathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants195 Participants
PSI VPathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants269 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026