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

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.

Study Overview

• Status: Completed
• Conditions: Hospital-acquired Pneumonia; Ventilator-associated Pneumonia
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem	Percentage	April 2017 - May 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of susceptibility to non-beta lactam antipseudomonal agents	Percentage	April 2017 - May 2020
in-hospital mortality	Percentage	April 2017 - May 2020
need for mechanical ventilation	Percentage	April 2017 - May 2020
duration of mechanical ventilation	number of days	April 2017 - May 2020
development of septic shock	Percentage	April 2017 - May 2020
ICU length of stay	number of days	April 2017 - May 2020
hospital length of stay	number of days	April 2017 - May 2020

Collaborators and Investigators

• Sponsor: Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2020
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 7, 2021

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia; Pneumonia, Ventilator-Associated
• Other Study ID Numbers: 046.PHA.2020.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No