Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-24 @ 10:41 PM
NCT ID:
NCT05545735
Eligibility Criteria:
Inclusion Criteria:
1. Surgical patient
2. Early VAP, defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube) (9). VAP will be defined according to local institutional protocol.
3. Hospital length of stay (LOS) \< 10 days at the time of VAP diagnosis.
4. Patients are willing to provide informed consent or their Legally Authorized Representative (LAR) is willing to provide informed consent on their behalf when the patient is unable (i.e., cognitively impaired from sedation on a ventilator)
Exclusion Criteria:
1. Age \< 18 years
2. Prior episode of VAP for the index admission
3. 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
4. Causative pathogen not sensitive to choice of initial empiric antibiotic
5. Antibiotic therapy for \> 5 of the last 10 days preceding VAP diagnosis
6. Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring \> 1 vasopressor (17)
7. Current or recent (within 30 days) use of immunosuppressive medications
8. LOS \> 72 hours at a transferring facility
9. Pregnancy or lactation
10. Legal arrest or incarceration
11. Moribund state in which death is imminent
12. ECMO (Extracorporeal membrane oxygenation)
13. Extubation prior to randomization
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05545735
Study Brief:
Protocol Section:
NCT05545735