Diagnostic Stewardship for Ventilator Associated Pneumonia

University of Maryland Baltimore (UMB)

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Other: Modified lab reporting

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05989269

HP-00100090

Details and patient eligibility

About

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 patients who have respiratory cultures obtained, but do not meet clinical criteria for ventilator associated pneumonia (VAP). The main question it aims to answer is: Does a modified culture reporting intervention reduce unnecessary antibiotics for ventilated patients in the intensive care unit (ICU)? Researchers will compare antibiotic use outcomes between eligible patients whose test results are communicated using the modified reporting and those with standard reporting of results.

Full 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 on antibiotic use, VAP diagnoses, and adverse events.

Hypothesis: A change in unnecessary antibiotics for VAP and in VAP clinical diagnoses in the intervention vs. control periods across all sites, without a change in adverse events, is expected.

Specific Aim 2: Evaluate overall impact of intervention including clinical and antibiotic outcomes using the "Desirability of Outcome Ranking (DOOR)/ Response Adjusted for Duration of Antibiotic Risk (RADAR)" methodology.

Hypothesis: A change in overall patient outcomes (better DOOR ranking, accounting for duration of antibiotic use) in the intervention vs. control period is expected.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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161 participants in 2 patient groups

Control Period

No Intervention group

Description:

Laboratory reporting of respiratory cultures will continue per regular or routine laboratory protocols (standard reporting).

Intervention

Other group

Description:

The lab will publish a modified report for respiratory cultures which do not meet clinical criteria for pneumonia and have growth of organisms (other than normal respiratory flora). The modified report will include the likelihood of colonization instead of reporting bacterial identification.

Treatment:

Other: Modified lab reporting