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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05545735
• Collaborator: (none)
• Enrollment: 458
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 24
• Patients Per Site Per Month: 19.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ventilator Associated Pneumonia	Drug: Standard of Care Antibiotic Therapy	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 458 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 15, 2022
• Anticipated Primary Completion Date: Dec 15, 2024
• Anticipated Study Completion Date: Dec 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Drug: Standard of Care Antibiotic Therapy; Antibiotics will be administered as per the standard of care orally via tablet
Active Comparator: 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).	Drug: Standard of Care Antibiotic Therapy; Antibiotics will be administered as per the standard of care orally via tablet

Outcome Measures

Primary Outcome Measures

1. 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.

2. Antibiotic Free Days [Up to 30 days]

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

Secondary Outcome Measures

1. Number of days of antibiotic exposure [Up to 30 days]

   The number of days when the participant received antibiotics

2. 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

3. 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.

4. Number of participants with VAP relapse [Up to 30 days]

   VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.

5. Ventilator-free days [Up to 30 days]

   The average number of days participants did not use a ventilator

6. The number of participants with empyema [Up to 30 days]

   The number of participants with empyema

7. The number of participants that received a tracheostomy [Up to 30 days]

   The number of participants that received a tracheostomy

8. The number of participants with Non-pulmonary infections [Up to 30 days]

   The number of participants with Non-pulmonary infections

9. ICU-free days [Up to 30 days]

   The average number of days participants were not in the ICU

10. Hospital Length Of Stay [Up to 1 year]

    Number of days participant was admitted in the hospital

11. In-hospital Mortality [Up to 1 year]

    The number of participants that died while admitted in the hospital will be reported

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Causative pathogen not sensitive to choice of initial empiric antibiotic

2. Antibiotic therapy for > 5 of the last 10 days preceding VAP diagnosis

3. Septic shock, defined as evidence of tissue hypoperfusion after adequate volume expansion, due to infection, and requiring > 1 vasopressor (17)

4. Current or recent (within 30 days) use of immunosuppressive medications

5. LOS > 72 hours at a transferring facility

6. Pregnancy or lactation

7. Legal arrest or incarceration

8. Moribund state in which death is imminent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jackson Memorial Hospital	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Jonathan Meizoso, MD, MSPH, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jonathan Meizoso, Assistant Professor of Surgery, University of Miami
• ClinicalTrials.gov Identifier: NCT05545735
• Other Study ID Numbers: 20211211
• First Posted: Sep 19, 2022
• Last Update Posted: Sep 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Anti-Bacterial Agents

Study Results

No Results Posted as of Sep 19, 2022