Trial Outcomes & Findings for The Duration of Antibiotic Therapy for Early (DATE) Ventilator Associated Pneumonia (VAP): 4 vs. 7 Days (NCT NCT05545735)

Results Overview

VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

27 participants

Primary outcome timeframe

Up to 21 days

Results posted on

2026-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	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). Standard of Care Antibiotic Therapy: 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). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Overall Study STARTED	12	15
Overall Study COMPLETED	12	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	Total n=27 Participants Total of all reporting groups
Age, Continuous	51 years n=9 Participants	43 years n=6 Participants	47 years n=9 Participants
Sex: Female, Male Female	1 Participants n=9 Participants	2 Participants n=6 Participants	3 Participants n=9 Participants
Sex: Female, Male Male	11 Participants n=9 Participants	13 Participants n=6 Participants	24 Participants n=9 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=9 Participants	7 Participants n=6 Participants	12 Participants n=9 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=9 Participants	2 Participants n=6 Participants	6 Participants n=9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=9 Participants	6 Participants n=6 Participants	9 Participants n=9 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants	1 Participants n=6 Participants	2 Participants n=9 Participants
Race (NIH/OMB) White	7 Participants n=9 Participants	7 Participants n=6 Participants	14 Participants n=9 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=6 Participants	0 Participants n=9 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=9 Participants	7 Participants n=6 Participants	11 Participants n=9 Participants
Number of Subjects with causative pathogen sensitive to initial empiric antibiotic	12 Participants n=9 Participants	15 Participants n=6 Participants	27 Participants n=9 Participants

PRIMARY outcome

Timeframe: Up to 21 days

VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Number of Participants With Reoccurring VAP	5 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 30 days

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

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Antibiotic Free Days	17.2 Days Standard Deviation 7.7	14 Days Standard Deviation 6.6

SECONDARY outcome

Timeframe: Up to 30 days

The number of days when the participant received antibiotics

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Number of Days of Antibiotic Exposure	12.8 Days Standard Deviation 7.7	16 Days Standard Deviation 6.6

SECONDARY outcome

Timeframe: Up to 30 days

Antibiotic exposure will be expressed as the total number of antibiotic days, defined as one antibiotic agent administered for one day. For example, if a patient receives two different antibiotics for five days, this equals 10 antibiotic days. The "number of antibiotics used" refers to the number of different antibiotic agents administered per day, not the number of individual doses or pills.

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Amount of Antibiotic Exposure	21.1 Antibiotic Days Standard Deviation 13.4	23.8 Antibiotic Days Standard Deviation 11.0

SECONDARY outcome

Timeframe: From baseline to the last study day, up to 30 days

Clinical improvement will be measured comparing the difference from the first study day to the last study day 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. A negative change may suggest improvement while a positive difference may suggest a worsening.

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Clinical Improvement as Measured by the Change in Clinical Pulmonary Infection Score (CPIS) From the First Study Day to the Last	-2 Change of score on a scale Interval -4.0 to 3.0	-1 Change of score on a scale Interval -7.0 to 1.0

SECONDARY outcome

Timeframe: Up to 30 days

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

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Number of Participants With VAP Relapse	1 Participants	4 Participants

SECONDARY outcome

Timeframe: Up to 30 days

The average number of days participants did not use a ventilator

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Ventilator-free Days	17.7 Days Standard Deviation 5.3	13.3 Days Standard Deviation 11.1

SECONDARY outcome

Timeframe: Up to 30 days

The number of participants with empyema

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
The Number of Participants With Empyema	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 30 days

The number of participants that received a tracheostomy

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
The Number of Participants That Received a Tracheostomy	2 Participants	8 Participants

SECONDARY outcome

Timeframe: Up to 30 days

The number of participants with Non-pulmonary infections

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
The Number of Participants With Non-pulmonary Infections	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 30 days

The average number of days participants were not in the ICU

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
ICU-free Days	11.8 Days Standard Deviation 9.7	7.2 Days Standard Deviation 6.4

SECONDARY outcome

Timeframe: Up to 1 year

Number of days participant was admitted in the hospital

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Hospital Length Of Stay	66.9 Days Standard Deviation 108.1	33.7 Days Standard Deviation 12.6

SECONDARY outcome

Timeframe: Up to 1 year

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

Outcome measures

Outcome measures
Measure	4 Days of Antibiotics Group n=12 Participants Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 Participants Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
In-hospital Mortality	2 Participants	1 Participants

Adverse Events

4 Days of Antibiotics Group

Serious events: 2 serious events

Other events: 0 other events

Deaths: 2 deaths

7 Days of Antibiotics Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	4 Days of Antibiotics Group n=12 participants at risk Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet	7 Days of Antibiotics Group n=15 participants at risk Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP). Standard of Care Antibiotic Therapy: Antibiotics will be administered as per the standard of care orally via tablet
Nervous system disorders Brain Death	16.7% 2/12 • Number of events 2 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.	13.3% 2/15 • Number of events 2 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.
Nervous system disorders Worsening Brain Bleed	0.00% 0/12 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.
Vascular disorders Above the Knee Amputation	0.00% 0/12 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.
Infections and infestations Blood Stream Infection	0.00% 0/12 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed for up to 1 year. Serious and Other (Not Including Serious) Adverse Events were assessed for 30 days from admission or until hospital discharge, whichever occurred first. This patient population who require critical care support will experience a number of common aberrations in laboratory values, signs, and symptoms due to the severity of the underlying disease and the impact of standard therapies. These will not necessarily constitute an AE unless they require significant intervention, lead to discontinuation of study procedures, felt to be related to study procedures or are considered to be of concern in the Investigator's clinical judgment.

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jonathan Meizoso

University of Miami

Phone: 305-585-1178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place