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

Phase 4

Terminated

• Conditions: Ventilator Associated Pneumonia
• Interventions: Drug: Standard of Care Antibiotic Therapy

• Registration Number: NCT05545735
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Study Start: 2023-05-08
• Primary Completion: 2025-02-27
• Study Completion: 2025-02-27
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4 Days of Antibiotics Group	Standard of Care Antibiotic Therapy	Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
7 Days of Antibiotics Group	Standard of Care Antibiotic Therapy	Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).

Primary Outcome Measures

Name	Time	Method
Number of participants with reoccurring VAP	Up to 21 days	VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Antibiotic Free Days	Up to 30 days	The number of days where participant did not require the use of antibiotics

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jackson Memorial Hospital; 🇺🇸 Miami, Florida, United States