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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04700202
Enrollment
132
Registered
2021-01-07
Start date
2020-06-30
Completion date
2022-12-15
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-acquired Pneumonia, Ventilator-associated Pneumonia

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.

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.

Interventions

OTHERObservational

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

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenemApril 2017 - May 2020Percentage

Secondary

MeasureTime frameDescription
Rate of susceptibility to non-beta lactam antipseudomonal agentsApril 2017 - May 2020Percentage
in-hospital mortalityApril 2017 - May 2020Percentage
need for mechanical ventilationApril 2017 - May 2020Percentage
duration of mechanical ventilationApril 2017 - May 2020number of days
development of septic shockApril 2017 - May 2020Percentage
ICU length of stayApril 2017 - May 2020number of days
hospital length of stayApril 2017 - May 2020number of days

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMatthew Crotty, PharmD

Methodist Health System

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026