The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days

• Status: Not yet recruiting
• Trial end date: 2024-12-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if the amount of antibiotics given for ventilator-associated pneumonia (VAP) can be decreased in order to reduce the risk of adverse effects associated with antibiotics, while at the same time ensuring the participant's safety.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Anti-Bacterial Agents

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