4 Days of Antibiotics Group for Ventilator Associated Bacterial Pneumonia

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Jackson Memorial Hospital, Miami, FL
Ventilator Associated Bacterial Pneumonia+2 More
Standard of Care Antibiotic Therapy - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Ventilator Associated Bacterial Pneumonia

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Other trials for Ventilator Associated Bacterial Pneumonia

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: Up to 1 year

Up to 1 year
Hospital Length Of Stay
In-hospital Mortality
Up to 21 days
Number of participants with reoccurring VAP
Up to 30 days
Amount of antibiotic exposure
Antibiotic Free Days
Clinical improvement as measured by the Clinical Pulmonary Infection Score
ICU-free days
Number of days of antibiotic exposure
Number of participants with VAP relapse
The number of participants that received a tracheostomy
The number of participants with Non-pulmonary infections
The number of participants with empyema
Ventilator-free days

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Ventilator Associated Bacterial Pneumonia

Trial Design

2 Treatment Groups

7 Days of Antibiotics Group
1 of 2
4 Days of Antibiotics Group
1 of 2
Active Control
Experimental Treatment

458 Total Participants · 2 Treatment Groups

Primary Treatment: 4 Days of Antibiotics Group · No Placebo Group · Phase 4

4 Days of Antibiotics Group
Drug
Experimental Group · 1 Intervention: Standard of Care Antibiotic Therapy · Intervention Types: Drug
7 Days of Antibiotics Group
Drug
ActiveComparator Group · 1 Intervention: Standard of Care Antibiotic Therapy · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year

Trial Background

Prof. Jonathan Meizoso, Assistant Professor of Surgery
Principal Investigator
University of Miami
Closest Location: Jackson Memorial Hospital · Miami, FL
Photo of Miami  1Photo of Miami  2Photo of Miami  3
2011First Recorded Clinical Trial
1 TrialsResearching Ventilator Associated Bacterial Pneumonia
68 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing to provide informed consent or your LAR is willing to provide informed consent on your behalf when you are unable to provide informed consent.
Early VAP is defined as VAP occurring within 2 - 7 days of intubation (via endotracheal or tracheostomy tube)
You have been hospitalized for 10 days or less at the time of VAP diagnosis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.