Status:

COMPLETED

Diagnostic Stewardship for Ventilator Associated Pneumonia

Lead Sponsor:

University of Maryland, Baltimore

Collaborating Sponsors:

Centers for Disease Control and Prevention

George Washington University

Conditions:

Ventilator Associated Pneumonia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The goal of this pragmatic cluster-randomized crossover trial is to test if less unnecessary antibiotics are prescribed when the lab reports respiratory culture test results in a specific way for pati...

Detailed Description

The specific aims of this project are: Specific Aim 1: In a cluster-randomized crossover trial among 6 ICUs across 3 medical centers, evaluate the impact of a VAP diagnostic stewardship intervention ...

Eligibility Criteria

Inclusion

  • Patient located on ICU unit included in the study
  • Patient is mechanically ventilated
  • Patient had respiratory culture sent \>48 hours after admission
  • Patient age ≥ 18 years

Exclusion

  • Extra corporeal membrane oxygenation (ECMO) at time of respiratory culture
  • Heart or lung transplant
  • Culture rejected by lab per standard lab protocol
  • Prisoners
  • Severe immunosuppression as defined by:
  • \<6 months from solid organ transplant (SOT) OR \<6 months from treatment for acute rejection following SOT
  • Active treatment for lymphoreticular malignancies
  • Neutropenic \< 1000
  • Receiving lymphodepleting chemotherapy
  • Allogeneic stem cell transplants \<6 months
  • Autologous stem cell transplants or chimeric antigen receptor T-cell (CAR-T) therapy \<6 months out
  • Allogeneic stem cell transplant with graft vs host disease (GVHD) or receiving 2 or more immunosuppressants
  • Advanced or untreated human immunodeficiency virus (HIV) infection with CD4 \< 200
  • Receiving biologics within 6 months

Key Trial Info

Start Date :

August 21 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2025

Estimated Enrollment :

161 Patients enrolled

Trial Details

Trial ID

NCT05989269

Start Date

August 21 2023

End Date

March 30 2025

Last Update

November 24 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

University of Maryland

Baltimore, Maryland, United States, 21201

2

Baylor College of Medicine

Houston, Texas, United States, 77030

3

Virginia Commonwealth University

Richmond, Virginia, United States, 23284