Diagnostic Stewardship for Ventilator-Associated Pneumonia

No longer recruiting at 2 trial locations
MN
SL
Overseen BySurbhi Leekha, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if changing how lab results are reported can reduce unnecessary antibiotic use in ICU patients on ventilators. It focuses on patients who don't meet the full criteria for ventilator-associated pneumonia but have respiratory cultures taken. The trial compares outcomes between those receiving standard lab reporting and those receiving a modified lab reporting intervention that provides more context about bacterial presence. It suits ICU patients who are mechanically ventilated and had a respiratory culture taken more than 48 hours after admission. As an unphased trial, this study allows patients to contribute to improving healthcare practices without the risks of testing new drugs.

Do I have to stop taking my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on antibiotic use, so it's possible that changes to your antibiotic regimen might be discussed with your healthcare provider.

What prior data suggests that this modified lab reporting is safe for ventilated patients?

Research has shown that altering lab report formats can help doctors use antibiotics more effectively for patients on ventilators. One study used a tool to modify lab reports, aiding doctors in determining the necessity of antibiotics. Another study tested a new method to track pneumonia cases in hospitals using these modified reports. These studies suggest that changing lab reports is safe and improves treatment decisions. No reports of harm from using these modified lab reports have emerged, indicating that this approach is likely safe for patients.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new method of lab reporting that could significantly impact the management of ventilator-associated pneumonia (VAP). Unlike standard practices that identify all organisms found in respiratory cultures, this new approach focuses on identifying the likelihood of colonization rather than simply reporting bacterial growth. This can help reduce unnecessary antibiotic use by distinguishing between actual infections and harmless colonizations. By potentially curbing antibiotic overuse, this method could lead to better patient outcomes and help combat antibiotic resistance.

What evidence suggests that this modified lab reporting is effective for reducing unnecessary antibiotics in ventilated patients?

This trial will compare standard laboratory reporting with a modified lab reporting intervention for respiratory cultures in patients with suspected ventilator-associated pneumonia. Research has shown that changing how lab results are reported can reduce unnecessary antibiotic use. One study showed that altering result presentation helped doctors avoid treating asymptomatic bacteria in urine. Another study found that when lab reports indicated harmless bacteria, antibiotic use decreased. These changes help doctors more accurately determine when antibiotics are needed, which is especially beneficial for ICU patients with suspected ventilator-related lung infections. Overall, this approach appears promising in reducing unnecessary antibiotic use.12467

Who Is on the Research Team?

SL

Surbhi Leekha, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are in the ICU, on a ventilator, and have had a respiratory culture taken more than 48 hours after admission. It's not for patients with severe immune system issues, recent transplants or certain therapies, ECMO at culture time, prisoners, or if the lab rejected their sample.

Inclusion Criteria

Patient located on ICU unit included in the study
You are using a machine to help you breathe.
You had a respiratory sample taken more than 48 hours after being admitted to the hospital.

Exclusion Criteria

I have not had a solid organ transplant or treatment for rejection in the last 6 months.
I had a stem cell transplant and am experiencing GVHD or taking 2 or more immunosuppressants.
I had a stem cell transplant or CAR-T therapy less than 6 months ago.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

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

6 months

Intervention Period

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).

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

What Are the Treatments Tested in This Trial?

Interventions

  • Modified lab reporting
Trial Overview The study tests whether changing how labs report respiratory test results can reduce unnecessary antibiotic use in ICU patients on ventilators without clinical signs of pneumonia. Patients will be compared based on modified versus standard result reporting methods.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Group II: Control PeriodActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Centers for Disease Control and Prevention

Collaborator

Trials
902
Recruited
25,020,000+

George Washington University

Collaborator

Trials
263
Recruited
476,000+

Baylor College of Medicine

Collaborator

Trials
1,044
Recruited
6,031,000+

Virginia Commonwealth University

Collaborator

Trials
732
Recruited
22,900,000+

Published Research Related to This Trial

The study at Monte Naranco Hospital revealed a total prevalence of adverse events of 7%, with significant increases in reporting from 300 incidents in 2004 to 2269 in 2006, highlighting the effectiveness of implementing multiple reporting systems and a dedicated clinical risk manager.
The analysis showed that while the reporting systems improved the understanding of adverse events, they also indicated the need for prioritization and cost-effective measures to better manage and mitigate these incidents in the future.
[Use of different patient safety reporting systems: much ado about nothing?].Dolores Menéndez, M., Rancaño, I., García, V., et al.[2014]
In a study involving 59 critical-care clinicians, attributes like new radiograph opacity, hypotension, fever, and copious sputum were identified as having the highest perceived diagnostic value for ordering respiratory cultures to diagnose ventilator-associated pneumonia (VAP).
The findings suggest that the emphasis on fever and hypotension may lead to overdiagnosis of VAP, indicating a need for improved diagnostic stewardship in critical care settings.
Understanding healthcare provider preferences for ordering respiratory cultures to diagnose ventilator associated pneumonia: A discrete choice experiment.Kenaa, B., O'Hara, NN., O'Hara, LM., et al.[2022]
Implementing MALDI-TOF mass spectrometry for rapid organism identification, along with pharmacy stewardship interventions, significantly reduced 30-day mortality in patients with bloodstream infections from 21% to 12%.
Despite the initial costs of MALDI-TOF equipment and dedicated pharmacist time, the total hospital costs per bloodstream infection decreased by $2,439, leading to an estimated annual savings of $2.34 million.
Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections.Patel, TS., Kaakeh, R., Nagel, JL., et al.[2022]

Citations

Improving Antibiotic Use for Ventilator-Associated ...Modified laboratory reporting has been particularly successful in decreasing the inappropriate treatment of asymptomatic bacteriuria and in de-escalation of ...
A quasi-experimental study of a bundled diagnostic ...We developed and implemented a VAP-DSI using an interruptive clinical decision support tool and modifications to clinical laboratory workflows.
Ventilator-associated Pneumonia (VAP) Diagnostic ...Study intervention: respiratory culture results will be automatically released in the EMR only for BAL samples with a polymorphonuclear (PMN) percentage of >50% ...
A Proof-of-Concept Mixed Methods Study | Request PDFIn a recent proof of concept study, we found that the modification of the respiratory culture report to suggest colonization results in ...
A qualitative assessment of the diagnosis and ...Quantitative versus qualitative cultures of respiratory secretions for clinical outcomes in patients with ventilator-associated pneumonia.
Surveillance of ventilator associated pneumonia in a network ...We conducted this observational pilot study to develop and test a modified surveillance definition for VAP in a few hospitals of this network.
Pneumonia (Ventilator-associated [VAP] and non- ...Refer to the table below if your laboratory reports these data semi-quantitatively or uses a different format for reporting Gram stain or ...
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