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Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04700202
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2021
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

Study Description
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Brief Summary:
Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.

Condition or disease Intervention/treatment
Ventilator-associated Pneumonia Hospital-acquired Pneumonia Other: Observational

Detailed Description:
Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP. Patients with respiratory culture data signifying a Gram-negative organism as the cause of HAP/VAP will be analyzed as described below if study inclusion criteria is met. Minimum inhibitory concentration (MIC) data will interpreted per Clinical & Laboratory Standards Institute (CLSI) standards to determine local patterns of resistance. Multivariable logistic regression will be performed to determine risk factors for piperacillin-tazobactam, cefepime or meropenem resistant Gram-negative isolates. Project target date of completion and close-out is May 2021.
Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Identifying Risk Factors for Gram-negative Resistance for HAP/VAP in the Intensive Care Unit
Actual Study Start Date : June 30, 2020
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : June 3, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Retrospective Cohort
Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.
 Other: Observational
Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP


Outcome Measures
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Primary Outcome Measures :
  1. Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem [ Time Frame: April 2017 - May 2020 ]
    Percentage


Secondary Outcome Measures :
  1. Rate of susceptibility to non-beta lactam antipseudomonal agents [ Time Frame: April 2017 - May 2020 ]
    Percentage

  2. in-hospital mortality [ Time Frame: April 2017 - May 2020 ]
    Percentage

  3. need for mechanical ventilation [ Time Frame: April 2017 - May 2020 ]
    Percentage

  4. duration of mechanical ventilation [ Time Frame: April 2017 - May 2020 ]
    number of days

  5. development of septic shock [ Time Frame: April 2017 - May 2020 ]
    Percentage

  6. ICU length of stay [ Time Frame: April 2017 - May 2020 ]
    number of days

  7. hospital length of stay [ Time Frame: April 2017 - May 2020 ]
    number of days


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP.
Criteria

Inclusion Criteria:

  • ICU, Neuro critical care unit admission
  • Diagnosis of HAP or VAP
  • Respiratory culture positive for Gram-negative organism

Exclusion Criteria:

  • ICU length of stay <48 hours prior to HAP/VAP
  • Culture or MIC data unavailable
  • Pregnant
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04700202


Locations
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United States, Texas
Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Matthew Crotty, PharmD Methodist Health System
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04700202    
Other Study ID Numbers: 046.PHA.2020.D
First Posted: January 7, 2021    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
 Respiratory Tract Diseases
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes