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

Sponsor

Methodist Health System (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04700202

Collaborator

(none)

500

Enrollment

Location

23.1

Anticipated Duration (Months)

21.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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

Study Type:

Observational

Anticipated 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 :

Jun 30, 2020

Anticipated Primary Completion Date :

Jun 3, 2022

Anticipated Study Completion Date :

Jun 3, 2022

Arms and Interventions

Arm	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

Arm

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

Primary Outcome Measures

Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem [April 2017 - May 2020]
Percentage

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	Methodist Dallas Medical Center	Dallas	Texas	United States	75203

Sponsors and Collaborators

Methodist Health System

Investigators

Principal Investigator: Matthew Crotty, PharmD, Methodist Health System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Methodist Health System

ClinicalTrials.gov Identifier:

NCT04700202

Other Study ID Numbers:

046.PHA.2020.D

First Posted:

Jan 7, 2021

Last Update Posted:

Dec 10, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pneumonia

Pneumonia, Ventilator-Associated

Healthcare-Associated Pneumonia

Study Results

No Results Posted as of Dec 10, 2021