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

NCT ID: NCT05545735

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2025-02-27

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.

Conditions

Ventilator Associated Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Standard of Care Antibiotic Therapy

Intervention Type: DRUG

Antibiotics will be administered as per the standard of care orally via tablet

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).

Group Type: ACTIVE_COMPARATOR

Standard of Care Antibiotic Therapy

Intervention Type: DRUG

Antibiotics will be administered as per the standard of care orally via tablet

Interventions

Standard of Care Antibiotic Therapy

Antibiotics will be administered as per the standard of care orally via tablet

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Meizoso

Assistant Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Meizoso, MD, MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Jackson Memorial Hospital

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20211211

Identifier Type: -

Identifier Source: org_study_id