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

NCT ID: NCT04700202

Last Updated: 2023-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-30

Study Completion Date

2022-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventilator-associated Pneumonia Hospital-acquired Pneumonia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Observational

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Methodist Health System

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Crotty, PharmD

Role: PRINCIPAL_INVESTIGATOR

Methodist Health System

Locations

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Methodist Dallas Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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046.PHA.2020.D

Identifier Type: -

Identifier Source: org_study_id

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