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

Primary Purpose

Ventilator Associated Pneumonia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Antibiotic Therapy
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventilator Associated Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jackson Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4 Days of Antibiotics Group

7 Days of Antibiotics Group

Arm Description

Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).

Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of days of antibiotic exposure
The number of days when the participant received antibiotics
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
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.
Number of participants with VAP relapse
VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.
Ventilator-free days
The average number of days participants did not use a ventilator
The number of participants with empyema
The number of participants with empyema
The number of participants that received a tracheostomy
The number of participants that received a tracheostomy
The number of participants with Non-pulmonary infections
The number of participants with Non-pulmonary infections
ICU-free days
The average number of days participants were not in the ICU
Hospital Length Of Stay
Number of days participant was admitted in the hospital
In-hospital Mortality
The number of participants that died while admitted in the hospital will be reported

Full Information

First Posted
September 12, 2022
Last Updated
May 9, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05545735
Brief Title
The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 Days of Antibiotics Group
Arm Type
Experimental
Arm Description
Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Arm Title
7 Days of Antibiotics Group
Arm Type
Active Comparator
Arm Description
Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Intervention Type
Drug
Intervention Name(s)
Standard of Care Antibiotic Therapy
Intervention Description
Antibiotics will be administered as per the standard of care orally via tablet
Primary Outcome Measure Information:
Title
Number of participants with reoccurring VAP
Description
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Time Frame
Up to 21 days
Title
Antibiotic Free Days
Description
The number of days where participant did not require the use of antibiotics
Time Frame
Up to 30 days
Secondary Outcome Measure Information:
Title
Number of days of antibiotic exposure
Description
The number of days when the participant received antibiotics
Time Frame
Up to 30 days
Title
Amount of antibiotic exposure
Description
Amount of antibiotic exposure is calculated by the days of antibiotics used multiplied by the number of antibiotics used per day
Time Frame
Up to 30 days
Title
Clinical improvement as measured by the Clinical Pulmonary Infection Score
Description
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.
Time Frame
Up to 30 days
Title
Number of participants with VAP relapse
Description
VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.
Time Frame
Up to 30 days
Title
Ventilator-free days
Description
The average number of days participants did not use a ventilator
Time Frame
Up to 30 days
Title
The number of participants with empyema
Description
The number of participants with empyema
Time Frame
Up to 30 days
Title
The number of participants that received a tracheostomy
Description
The number of participants that received a tracheostomy
Time Frame
Up to 30 days
Title
The number of participants with Non-pulmonary infections
Description
The number of participants with Non-pulmonary infections
Time Frame
Up to 30 days
Title
ICU-free days
Description
The average number of days participants were not in the ICU
Time Frame
Up to 30 days
Title
Hospital Length Of Stay
Description
Number of days participant was admitted in the hospital
Time Frame
Up to 1 year
Title
In-hospital Mortality
Description
The number of participants that died while admitted in the hospital will be reported
Time Frame
Up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 LOS > 72 hours at a transferring facility Pregnancy or lactation Legal arrest or incarceration Moribund state in which death is imminent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Meizoso, MD, MSPH
Phone
305-585-1178
Email
jpmeizoso@med.miami.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ron Manning, APRN, MSPH
Phone
305-355-4972
Email
rmanning@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Meizoso, MD, MSPH
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Meizoso, MD, MSPH

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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