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

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

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.

Study Overview

• Status: Terminated
• Conditions: Ventilator Associated Pneumonia
• Intervention / Treatment: Drug: Standard of Care Antibiotic Therapy

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Drug: Standard of Care Antibiotic Therapy; Antibiotics will be administered as per the standard of care orally via tablet
Active Comparator: 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).	Drug: Standard of Care Antibiotic Therapy; Antibiotics will be administered as per the standard of care orally via tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Free Days	The number of days where participant did not require the use of antibiotics	Up to 30 days
Number of Participants With Reoccurring VAP	VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.	Up to 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length Of Stay	Number of days participant was admitted in the hospital	Up to 1 year
In-hospital Mortality	The number of participants that died while admitted in the hospital will be reported	Up to 1 year
Number of Days of Antibiotic Exposure	The number of days when the participant received antibiotics	Up to 30 days
Amount of Antibiotic Exposure	Antibiotic exposure will be expressed as the total number of antibiotic days, defined as one antibiotic agent administered for one day. For example, if a patient receives two different antibiotics for five days, this equals 10 antibiotic days. The "number of antibiotics used" refers to the number of different antibiotic agents administered per day, not the number of individual doses or pills.	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	Clinical improvement will be measured comparing the difference from the first study day to the last study day using daily Clinical Pulmonary Infection Score (CPIS) clinical score while enrolled in the study. CPIS has a total score ranging from 0 to 12 where a score of less than 6 indicates that the lung infection is considered controlled. A negative change may suggest improvement while a positive difference may suggest a worsening.	From baseline to the last study day, up to 30 days
Number of Participants With VAP Relapse	VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.	Up to 30 days
Ventilator-free Days	The average number of days participants did not use a ventilator	Up to 30 days
The Number of Participants With Empyema	The number of participants with empyema	Up to 30 days
The Number of Participants That Received a Tracheostomy	The number of participants that received a tracheostomy	Up to 30 days
The Number of Participants With Non-pulmonary Infections	The number of participants with Non-pulmonary infections	Up to 30 days
ICU-free Days	The average number of days participants were not in the ICU	Up to 30 days

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Jonathan Meizoso, MD, MSPH, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 16, 2022
• First Posted (Actual): September 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Healthcare-Associated Pneumonia; Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Cross Infection; Iatrogenic Disease; Pathological Conditions, Signs and Symptoms; Pneumonia, Ventilator-Associated; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 20211211

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No