Diagnostic Stewardship for Ventilator-Associated Pneumonia

No longer recruiting at 2 trial locations

Overseen By Surbhi Leekha, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Biologics, Immunosuppressants, Chemotherapy, others

Disqualifiers: ECMO, Transplant, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

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. ^{1 2 3 4 5}

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. ^{1 2 4 6 7}

Who Is on the Research Team?

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.

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?

Group I: Intervention Experimental Treatment 1 Intervention

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.

Group II: Control Period Active Control 1 Intervention

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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The streamlined definition of ventilator-associated pneumonia (VAP) significantly reduced the time needed for assessment from an average of 39 minutes to just 3.5 minutes per patient, making it a more efficient method for surveillance.

This new method also improved objectivity in assessments, as indicated by higher interrater reliability (κ 0.79 vs 0.45), while still predicting patient outcomes, such as ventilator days and hospital mortality, nearly as effectively as the conventional definition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid and reproducible surveillance for ventilator-associated pneumonia. Klompas, M., Kleinman, K., Khan, Y., et al.[2022]

Improving the safety culture in healthcare is expected to lead to increased reporting of adverse events, which can help identify and address issues in patient care.

Voluntary incident reporting systems, like the ICUSRS, can effectively highlight errors and develop evidence-based practices to enhance patient safety in the ICU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting errors in the ICU: use of a national database. Kleinpell, R., Thompson, D., Kelso, L., et al.[2018]

The study found that using a predefined list of harm scores in a voluntary medical incident reporting system can enhance the consistency and accuracy of reports, which is crucial for patient safety research.

Two coders achieved an 82% agreement rate when reviewing harm scores, indicating that a structured approach to reporting can significantly improve the quality of data collected for analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analyzing voluntary medical incident reports. Gong, Y., Richardson, J., Zhijian, L., et al.[2016]

The study analyzed voluntarily reported harmful patient safety events from 5038 patients across a healthcare system and found significant racial differences in reporting, with higher proportions of white patients and lower proportions of others in the Patient Safety Event Management System.

These differences were consistent across various hospitals and types of events, indicating a need for healthcare organizations to investigate potential reporting biases and understand the underlying causes of these disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Race Differences in Reported Harmful Patient Safety Events in Healthcare System High Reliability Organizations. Thomas, AD., Pandit, C., Krevat, SA.[2021]

Current methods for diagnosing pneumonia, especially in critically ill patients, are inadequate, often missing cases of bacterial ventilator-associated pneumonia (VAP) despite clinical evidence and treatment responses.

Promising new diagnostic technologies, such as nucleic-acid amplification and mass spectrometry, could enhance rapid identification of pathogens and improve targeted antibiotic treatment, potentially transforming patient care in pneumonia management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New diagnostic methods for pneumonia in the ICU. Douglas, IS.[2016]

A study involving 133 ICU physicians found that their estimates of the diagnostic probability for ventilator-associated pneumonia (VAP) were consistently higher than evidence-based probabilities, indicating a tendency to overdiagnose VAP.

Specific diagnostic indicators, such as positive bronchoalveolar lavage culture and chest radiographs, showed significant discrepancies between provider estimates and evidence-based likelihood ratios, suggesting a need for improved diagnostic accuracy and potential educational interventions to reduce overdiagnosis and unnecessary antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthcare providers consistently overestimate the diagnostic probability of ventilator-associated pneumonia. Soper, NS., Albin, OR.[2023]

The implementation of a voluntary and anonymous Web-based safety reporting system in intensive care units (ICUs) showed potential for enhancing patient safety by integrating with existing hospital reporting systems.

Most incident reports were completed by registered nurses, highlighting a gap in knowledge about current reporting systems, which suggests that better training and awareness could further improve the effectiveness of these safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating the intensive care unit safety reporting system with existing incident reporting systems. Thompson, DA., Lubomski, L., Holzmueller, C., et al.[2019]

A diagnostic stewardship program in a medical intensive care unit and five medicine units led to a significant reduction in blood culture (BCx) rates, from 27.7 to 22.8 BCx/100 patient-days in the MICU and from 10.9 to 7.7 BCx/100 patient-days in the combined medicine units, indicating improved optimization of BCx practices.

The program also resulted in an increase in BCx positivity in the MICU (from 8% to 11%) and a 21% decrease in solitary BCxs in the medicine units, demonstrating that clinician education and guidance can enhance the effectiveness of BCx without negatively impacting patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Diagnostic Stewardship Intervention To Improve Blood Culture Use among Adult Nonneutropenic Inpatients: the DISTRIBUTE Study. Fabre, V., Klein, E., Salinas, AB., et al.[2021]

In a study of 231 suspected ventilator-associated pneumonia (VAP) cases in ICUs, 58.4% were misdiagnosed and did not actually have VAP, leading to unnecessary antibiotic treatment.

Of the patients without VAP, 76% continued to receive antibiotics after 3 days, resulting in 1,183 excess days of antibiotic use, highlighting the need for better diagnostic practices to prevent over-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator-associated pneumonia: overdiagnosis and treatment are common in medical and surgical intensive care units. Nussenblatt, V., Avdic, E., Berenholtz, S., et al.[2021]

Laboratory testing plays a crucial role in patient outcomes, but its specific contributions are often difficult to quantify, highlighting the need for better measurement of its value in healthcare.

To enhance the effectiveness of laboratory medicine, it is essential to improve the use of biomarkers, establish standard protocols for evaluating clinical effectiveness, and foster collaboration between laboratory professionals and clinical staff, all aimed at optimizing patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving clinical outcomes - towards patient-centred laboratory medicine. Hallworth, MJ.[2019]

A 12-month analysis at a university hospital showed that implementing a computerized communication system significantly improved the timeliness of reporting critical laboratory values, which is essential for patient safety.

Automated communication not only reduces errors associated with manual reporting but also enhances the chances of reaching the on-call physician, thereby supporting timely clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of effectiveness of a computerized notification system for reporting critical values. Piva, E., Sciacovelli, L., Zaninotto, M., et al.[2022]

In a study involving 208 patients with pneumonia, the use of multiplex bacterial PCR on bronchoalveolar lavage fluid significantly reduced the duration of inappropriate antibiotic therapy by an average of 38.6 hours compared to conventional microbiology methods.

The findings suggest that multiplex bacterial PCR can enhance antibiotic stewardship in pneumonia patients at risk of Gram-negative infections, potentially leading to more effective and safer treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fast multiplex bacterial PCR of bronchoalveolar lavage for antibiotic stewardship in hospitalised patients with pneumonia at risk of Gram-negative bacterial infection (Flagship II): a multicentre, randomised controlled trial. Darie, AM., Khanna, N., Jahn, K., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

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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 ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1198743X23006316

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.

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05176353

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% ...

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A Proof-of-Concept Mixed Methods Study | Request PDF

In a recent proof of concept study, we found that the modification of the respiratory culture report to suggest colonization results in ...

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cambridge.org

cambridge.org/core/journals/infection-control-and-hospital-epidemiology/article/qualitative-assessment-of-the-diagnosis-and-management-of-ventilatorassociated-pneumonia-among-critical-care-clinicians-exploring-opportunities-for-diagnostic-stewardship/2A40C22858D5C795324017BC7147304A

A qualitative assessment of the diagnosis and ...

Quantitative versus qualitative cultures of respiratory secretions for clinical outcomes in patients with ventilator-associated pneumonia.

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11315213/

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.

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cdc.gov

cdc.gov/nhsn/pdfs/pscmanual/6pscvapcurrent.pdf

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 ...