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

Stopped early · Phase 4

Conditions studied: Ventilator Associated Pneumonia

In brief

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.

Key facts

Study ID

NCT05545735

Run by

University of Miami

People needed

27

Starts

2023-05-08

Expected to finish

2025-02-27

Last updated by the study team

2026-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Surgical patient
• 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.
• Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis.
• 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)

You may not qualify if…

• 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 volume expansion, 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

Where it is running

• Jackson Memorial Hospital — Miami, Florida, United States

Full record on ClinicalTrials.gov

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