Phase
Condition
Pneumonia
Treatment
Standard of Care Antibiotic Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Surgical patient
Early VAP, defined as VAP occurring within 2 - 7 days of intubation (viaendotracheal or tracheostomy tube) (9). VAP will be defined according to localinstitutional protocol.
Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
Patients are willing to provide informed consent or their Legally AuthorizedRepresentative (LAR) is willing to provide informed consent on their behalf when thepatient is unable (i.e., cognitively impaired from sedation on a ventilator)
Exclusion
Exclusion Criteria:
Age < 18 years
Prior episode of VAP for the index admission
VAP caused by any of the following pathogens:
Methicillin-resistant Staphylococcus aureus (MRSA)
Vancomycin-intermediate Staphylococcus aureus (VISA)
Pseudomonas aeruginosa
Vancomycin-resistant Enterococcus (VRE)
Acinetobacter baumanii
Stenotrophomonas maltophilia
Carbapenem-resistant Enterobacteriaceae (CRE)
Extended-spectrum beta lactamase-producing gram-negative bacilli
Causative pathogen not sensitive to choice of initial empiric antibiotic
Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis
Septic shock, defined as evidence of tissue hypoperfusion after adequate volumeexpansion, due to infection, and requiring > 1 vasopressor (17)
Current or recent (within 30 days) use of immunosuppressive medications
LOS > 72 hours at a transferring facility
Pregnancy or lactation
Legal arrest or incarceration
Moribund state in which death is imminent
ECMO (Extracorporeal membrane oxygenation)
Extubation prior to randomization
Study Design
Connect with a study center
Jackson Memorial Hospital
Miami, Florida 33136
United StatesSite Not Available
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