Clinical Characteristics and Microbiology of Healthcare Associated Pneumonia

September 7, 2020 updated by: Ping-Huai Wang, Far Eastern Memorial Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
530

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • New Taipei, Taiwan, 220
        • Far Eastern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathogens of Healthcare Associated Pneumonia, Measured by the Number of Participants
Time Frame: 7 days
sputum culture and sterile specimen such as blood or pleural effusion culture for healthcare associated pneumonia within seven days of admission
7 days
Number of Participants With MDR Pathogens
Time Frame: 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).
seven days after admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Far Eastern Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ping-huai Wang, M.D., Far Eastern Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 102013-E

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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