Clinical trial NCT05545735: The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days
Official title: Duration of Antibiotic Therapy for Early (DATE) Ventilator-Associated Pneumonia (VAP) Trial: A Surgical Infection Society Multicenter Randomized Clinical Trial of 4 vs. 7 Days of Definitive Antibiotic Therapy for Early VAP
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Ventilator Associated Pneumonia
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Number of participants with reoccurring VAP
timeFrame: Up to 21 days
measure: Antibiotic Free Days
timeFrame: Up to 30 days
Secondary outcomes:
measure: Number of days of antibiotic exposure
timeFrame: Up to 30 days
measure: Amount of antibiotic exposure
timeFrame: Up to 30 days
measure: Clinical improvement as measured by the Clinical Pulmonary Infection Score
timeFrame: Up to 30 days
measure: Number of participants with VAP relapse
timeFrame: Up to 30 days
measure: Ventilator-free days
timeFrame: Up to 30 days
measure: The number of participants with empyema
timeFrame: Up to 30 days
measure: The number of participants that received a tracheostomy
timeFrame: Up to 30 days
measure: The number of participants with Non-pulmonary infections
timeFrame: Up to 30 days
measure: ICU-free days
timeFrame: Up to 30 days
measure: Hospital Length Of Stay
timeFrame: Up to 1 year
measure: In-hospital Mortality
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Jonathan Meizoso, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: