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
Overview
- Phase
- Phase 4
- Intervention
- Standard of Care Antibiotic Therapy
- Conditions
- Ventilator Associated Pneumonia
- Sponsor
- University of Miami
- Enrollment
- 27
- Locations
- 1
- Primary Endpoint
- Antibiotic Free Days
- Status
- Terminated
- Last Updated
- 3 months ago
Overview
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.
Investigators
Jonathan Meizoso
Assistant Professor of Surgery
University of Miami
Eligibility Criteria
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:
- •Methicillin-resistant Staphylococcus aureus (MRSA)
- •Vancomycin-intermediate Staphylococcus aureus (VISA)
- •Pseudomonas aeruginosa
- •Vancomycin-resistant Enterococcus (VRE)
- •Acinetobacter baumanii
- •Stenotrophomonas maltophilia
- •Carbapenem-resistant Enterobacteriaceae (CRE)
Arms & Interventions
4 Days of Antibiotics Group
Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Intervention: Standard of Care Antibiotic Therapy
7 Days of Antibiotics Group
Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Intervention: Standard of Care Antibiotic Therapy
Outcomes
Primary Outcomes
Antibiotic Free Days
Time Frame: Up to 30 days
The number of days where participant did not require the use of antibiotics
Number of Participants With Reoccurring VAP
Time Frame: Up to 21 days
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Secondary Outcomes
- Hospital Length Of Stay(Up to 1 year)
- In-hospital Mortality(Up to 1 year)
- Number of Days of Antibiotic Exposure(Up to 30 days)
- Amount of Antibiotic Exposure(Up to 30 days)
- Clinical Improvement as Measured by the Change in Clinical Pulmonary Infection Score (CPIS) From the First Study Day to the Last(From baseline to the last study day, up to 30 days)
- Number of Participants With VAP Relapse(Up to 30 days)
- Ventilator-free Days(Up to 30 days)
- The Number of Participants With Empyema(Up to 30 days)
- The Number of Participants That Received a Tracheostomy(Up to 30 days)
- The Number of Participants With Non-pulmonary Infections(Up to 30 days)
- ICU-free Days(Up to 30 days)