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Standard of Care for Bacterial Pneumonia (PDP Trial)

N/A
Recruiting
Led By Kimberly E Hanson, MD, MHS
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, or up to 18 months, whichever comes first
Awards & highlights

PDP Trial Summary

The Pneumonia Direct Pilot study is designed to assess whether combining molecular diagnostics for bacteria and AMR markers with host-response profiling improves agreement and predictive value for the diagnosis of VAP versus an adjudicated clinical reference standard. The feasibility design is intended to inform future interventional studies that will investigate the clinical impact of combined pathogen- and host-directed testing approaches.

Eligible Conditions
  • Bacterial Pneumonia

PDP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, or up to 18 months, whichever comes first
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, or up to 18 months, whichever comes first for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with a clinical diagnosis of VAP at the time of clinical change
The number of participants with positive results on the FilmArray Pneumonia Panel (BioFire)
The number of participants with positive results on the Host gene expression
+6 more
Secondary outcome measures
Number of participants with an adjudicated diagnosis of of proven, probable, possible, or no VAP at the time of clinical change utilizing clinical and microbiological information

PDP Trial Design

1Treatment groups
Experimental Treatment
Group I: Standard of CareExperimental Treatment1 Intervention
There are no interventions in this study. Standard of care activities will be captured in the eCRF and samples will be collected and tested. Results will not be returned to the sites or participants.

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,480,882 Total Patients Enrolled
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,819 Total Patients Enrolled
Kimberly E Hanson, MD, MHSPrincipal InvestigatorUniversity of Utah

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pneumonia Direct Pilot
2024. "Pneumonia Direct Pilot". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06181669.
All > Cleveland > Paid Studies Pittsburgh
~167 spots leftby Sep 2024
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