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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Antibiotics will be administered as per the standard of care orally via tablet
Jackson Memorial Hospital
Miami, Florida, United States
Number of Participants With Reoccurring VAP
VAP recurrence will be reported as the number of participants with VAP occurring following completion of initial therapy.
Time frame: Up to 21 days
Antibiotic Free Days
The number of days where participant did not require the use of antibiotics
Time frame: Up to 30 days
Number of Days of Antibiotic Exposure
The number of days when the participant received antibiotics
Time frame: Up to 30 days
Amount of Antibiotic Exposure
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.
Time frame: 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
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.
Time frame: From baseline to the last study day, up to 30 days
Number of Participants With VAP Relapse
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
VAP relapse will be reported as any recurrence of VAP caused by initial pathogen.
Time frame: Up to 30 days
Ventilator-free Days
The average number of days participants did not use a ventilator
Time frame: Up to 30 days
The Number of Participants With Empyema
The number of participants with empyema
Time frame: Up to 30 days
The Number of Participants That Received a Tracheostomy
The number of participants that received a tracheostomy
Time frame: Up to 30 days
The Number of Participants With Non-pulmonary Infections
The number of participants with Non-pulmonary infections
Time frame: Up to 30 days
ICU-free Days
The average number of days participants were not in the ICU
Time frame: Up to 30 days
Hospital Length Of Stay
Number of days participant was admitted in the hospital
Time frame: Up to 1 year
In-hospital Mortality
The number of participants that died while admitted in the hospital will be reported
Time frame: Up to 1 year