Assessing diagnostic methods for ventilator-associated pneumonia

Pneumonia Direct Pilot

This study is testing a new way to diagnose ventilator-associated pneumonia in newly intubated adults in the ICU by looking at bacteria and the body's response to see if it helps doctors make better decisions.

Quick facts

• Study type: Observational
• Enrollment: 250 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Duke University (other)
• Locations: 4 sites (Detroit, Michigan and 3 other locations)
• Trial ID: NCT06181669 on ClinicalTrials.gov

What this trial studies

The Pneumonia Direct Pilot is an observational study aimed at evaluating the effectiveness of combining molecular diagnostics for bacteria and antimicrobial resistance markers with host-response profiling to improve the diagnosis of ventilator-associated pneumonia (VAP). Newly intubated adult patients in the ICU will be assessed for eligibility and will undergo blood sampling and collection of respiratory samples to gather data on pathogen and host responses. Participants will be monitored for clinical changes related to VAP for up to 14 days, with additional samples collected if a clinical suspicion of VAP arises. This study is designed to inform future interventional studies that may enhance clinical outcomes through improved diagnostic methods.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are newly intubated for less than 48 hours and are expected to require intubation for at least 48 hours.

Not a fit: Patients who are receiving comfort care or have known active lung cancer, cystic fibrosis, or are currently on antibiotics for suspected bacterial infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of ventilator-associated pneumonia, potentially improving patient outcomes.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving diagnostic accuracy for pneumonia, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Are ≥18 years old
2. Are newly intubated for less than 48 hours and for reasons other than suspected bacterial pneumonia or suspected acute bacterial infection
3. Are expected to require intubation for at least 48 hours, per the discretion of the treating clinician
4. Are able to provide protocol-accepted consent (legally authorized representative \[LAR\] is acceptable)
5. Are expected to live long enough to receive a VAP diagnosis, at the discretion of the treating clinician
6. Are able to provide study-required biological samples

Exclusion Criteria:

1. Have a witnessed or suspected aspiration event prompting the need for current, new intubation
2. Have known active lung cancer or metastatic disease to a lung
3. Received a lung transplant
4. Have cystic fibrosis
5. Are receiving comfort care
6. Are receiving antibiotic treatment for suspected or proven active acute bacterial infection (eg, pneumonia, tracheobronchitis, sepsis)
7. Have a current or within-the-last-30-days diagnosis of active bacterial pneumonia
8. Were previously enrolled in this trial
9. Require long-term ventilator support
10. Have a tracheostomy tube in place
11. Are currently participating in an interventional drug or device study.

Where this trial is running

Detroit, Michigan and 3 other locations

• Henry Ford Hospital — Detroit, Michigan, United States (RECRUITING)
• Corewell (William Beaumont) — Royal Oak, Michigan, United States (RECRUITING)
• Washington University School of Medicine in St. Louis — Saint Louis, Missouri, United States (RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Kimberly E Hanson, MD, MHS — University of Utah
• Study coordinator: Keri R Baum

Conditions: Pneumonia, Bacterial, Ventilator Associated Pneumonia