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Completed

NCT Number: NCT04700202

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.

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Key information

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

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

Primary outcomes

  1. Rate of Gram-negative isolate resistance to piperacillin-tazobactam, cefepime, meropenem

    Time frame: April 2017 - May 2020

    Percentage

Secondary outcomes

  1. Rate of susceptibility to non-beta lactam antipseudomonal agents

    Time frame: April 2017 - May 2020

    Percentage

  2. in-hospital mortality

    Time frame: April 2017 - May 2020

    Percentage

  3. need for mechanical ventilation

    Time frame: April 2017 - May 2020

    Percentage

  4. duration of mechanical ventilation

    Time frame: April 2017 - May 2020

    number of days

  5. development of septic shock

    Time frame: April 2017 - May 2020

    Percentage

  6. ICU length of stay

    Time frame: April 2017 - May 2020

    number of days

  7. hospital length of stay

    Time frame: April 2017 - May 2020

    number of days

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 7, 2021
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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