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

NCT04700202 | Completed

• 1 other identifier: 046.PHA.2020.D
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventilator-associated Pneumonia; Hospital-acquired Pneumonia

Outcome Measures

Primary Outcomes (1)

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

  Percentage

  April 2017 - May 2020

Secondary Outcomes (7)

• Rate of susceptibility to non-beta lactam antipseudomonal agents

  April 2017 - May 2020

• in-hospital mortality

  April 2017 - May 2020

• need for mechanical ventilation

  April 2017 - May 2020

• duration of mechanical ventilation

  April 2017 - May 2020

• development of septic shock

  April 2017 - May 2020

Study Arms (1)

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

Interventions

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

Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• ICU, Neuro critical care unit admission
• Diagnosis of HAP or VAP
• Respiratory culture positive for Gram-negative organism

You may not qualify if:

• ICU length of stay \<48 hours prior to HAP/VAP
• Culture or MIC data unavailable
• Pregnant

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Matthew Crotty, PharmD

  Methodist Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: January 7, 2021
• Study Start: June 30, 2020
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: March 23, 2026

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)