TerminatedPhase 4

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

Stopped: The rate of enrollment was slower than expected

United States27 participantsStarted 2023-05-08

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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)

Exclusion criteria

✕. Age \< 18 years
✕. Prior episode of VAP for the index admission
✕. VAP caused by any of the following pathogens:
✕. 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

What they're measuring

Number of Participants With Reoccurring VAP

Timeframe: Up to 21 days

Antibiotic Free Days

Timeframe: Up to 30 days

Trial details

NCT IDNCT05545735

SponsorUniversity of Miami

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-27

Results submitted2025-10-15

View on ClinicalTrials.gov More Ventilator Associated Pneumonia trials