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

Ventilator Associated Pneumonia Clinical Trial

— DATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05545735
• Other study ID #: 20211211
• Status: Recruiting
• Phase: Phase 4
• Start date: May 8, 2023
• Est. completion date: June 15, 2025

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: Jonathan Meizoso, MD, MSPH
• Phone: 305-585-1178
• Email: jpmeizoso[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 458
• Est. completion date: June 15, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Intervention

Drug:
• Standard of Care Antibiotic Therapy
Antibiotics will be administered as per the standard of care orally via tablet

Locations

Country	Name	City	State
United States	Jackson Memorial Hospital	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Antibiotic Free Days	The number of days where participant did not require the use of antibiotics	Up to 30 days
Secondary	Number of days of antibiotic exposure	The number of days when the participant received antibiotics	Up to 30 days
Secondary	Amount of antibiotic exposure	Amount of antibiotic exposure is calculated by the days of antibiotics used multiplied by the number of antibiotics used per day	Up to 30 days
Secondary	Clinical improvement as measured by the Clinical Pulmonary Infection Score	Clinical improvement will be measured 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.	Up to 30 days
Secondary	Number of participants with VAP relapse	VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.	Up to 30 days
Secondary	Ventilator-free days	The average number of days participants did not use a ventilator	Up to 30 days
Secondary	The number of participants with empyema	The number of participants with empyema	Up to 30 days
Secondary	The number of participants that received a tracheostomy	The number of participants that received a tracheostomy	Up to 30 days
Secondary	The number of participants with Non-pulmonary infections	The number of participants with Non-pulmonary infections	Up to 30 days
Secondary	ICU-free days	The average number of days participants were not in the ICU	Up to 30 days
Secondary	Hospital Length Of Stay	Number of days participant was admitted in the hospital	Up to 1 year
Secondary	In-hospital Mortality	The number of participants that died while admitted in the hospital will be reported	Up to 1 year