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

NCT05545735 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20211211
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• Antibiotic Free Days

  The number of days where participant did not require the use of antibiotics

  Up to 30 days

Secondary Outcomes (11)

• 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

Study Arms (2)

4 Days of Antibiotics Group

EXPERIMENTAL

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

7 Days of Antibiotics Group

ACTIVE COMPARATOR

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

Interventions

Standard of Care Antibiotic Therapy DRUG

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

4 Days of Antibiotics Group; 7 Days of Antibiotics Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)
• Extended-spectrum beta lactamase-producing gram-negative bacilli
• Causative pathogen not sensitive to choice of initial empiric antibiotic
• Antibiotic therapy for \> 5 of the last 10 days preceding VAP diagnosis
• Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring \> 1 vasopressor (17)
• Current or recent (within 30 days) use of immunosuppressive medications

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Memorial Hospital

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jonathan Meizoso
• Organization: University of Miami

jpmeizoso@med.miami.edu

305-585-1178

Study Officials

• Jonathan Meizoso, MD, MSPH

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 19, 2022
• Study Start: May 8, 2023
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)