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NCT04700202 Clinical Trial

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

Ventilator-associated Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04700202
Other study ID # 046.PHA.2020.D
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 30, 2020
Est. completion date December 15, 2022

Study information
Verified date February 2023
Source Methodist Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 132
Est. completion date December 15, 2022
Est. primary completion date December 15, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Methodist Dallas Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem Percentage April 2017 - May 2020
Secondary Rate of susceptibility to non-beta lactam antipseudomonal agents Percentage April 2017 - May 2020
Secondary in-hospital mortality Percentage April 2017 - May 2020
Secondary need for mechanical ventilation Percentage April 2017 - May 2020
Secondary duration of mechanical ventilation number of days April 2017 - May 2020
Secondary development of septic shock Percentage April 2017 - May 2020
Secondary ICU length of stay number of days April 2017 - May 2020
Secondary hospital length of stay number of days April 2017 - May 2020
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