Pneumonia Direct Pilot

Launched by DUKE UNIVERSITY · Dec 22, 2023

Keywords

ClinConnect Summary

The Pneumonia Direct Pilot study is looking at new ways to diagnose Ventilator-Associated Pneumonia (VAP), which is a type of lung infection that can occur in patients on breathing machines. Researchers want to see if using advanced tests that identify bacteria and check how the body is responding to infection can help doctors make more accurate diagnoses compared to traditional methods. This study is important because it could lead to better treatments and outcomes for patients with pneumonia in the future.

To be eligible for this study, participants need to be at least 18 years old, newly intubated (put on a breathing machine) for less than 48 hours for reasons other than suspected pneumonia, and expected to need the machine for at least 48 hours. Participants will provide samples for testing and can expect to be monitored closely during the study. It’s also important to note that certain conditions, like having active lung cancer or receiving treatment for an active infection, would exclude someone from participating. The study is currently recruiting patients, and everyone involved will receive care and support throughout the trial.

Gender

ALL

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.