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

Last updated: March 31, 2025
Sponsor: University of Miami
Overall Status: Terminated

Phase

4

Condition

Pneumonia

Treatment

Standard of Care Antibiotic Therapy

Clinical Study ID

NCT05545735
20211211
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Surgical patient

  2. 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.

  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 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:

  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

  1. Causative pathogen not sensitive to choice of initial empiric antibiotic

  2. Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis

  3. Septic shock, defined as evidence of tissue hypoperfusion after adequate volumeexpansion, due to infection, and requiring > 1 vasopressor (17)

  4. Current or recent (within 30 days) use of immunosuppressive medications

  5. LOS > 72 hours at a transferring facility

  6. Pregnancy or lactation

  7. Legal arrest or incarceration

  8. Moribund state in which death is imminent

  9. ECMO (Extracorporeal membrane oxygenation)

  10. Extubation prior to randomization

Study Design

Total Participants: 24
Treatment Group(s): 1
Primary Treatment: Standard of Care Antibiotic Therapy
Phase: 4
Study Start date:
May 08, 2023
Estimated Completion Date:
February 27, 2025

Connect with a study center

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Site Not Available

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