Your session is about to expire
← Back to Search
Antibiotic
Shortened Antibiotic Therapy for Ventilator-Associated Pneumonia (DATE Trial)
Phase 4
Recruiting
Led By Jonathan Meizoso, MD, MSPH
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Surgical patient
Hospital length of stay (LOS) < 10 days at the time of VAP diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
DATE Trial Summary
This trial will test if lowering the amount of antibiotics given for ventilator-associated pneumonia can reduce side effects, while still keeping patients safe.
Who is the study for?
This trial is for surgical patients with early ventilator-associated pneumonia (VAP) that occurred within 2-7 days of intubation, who haven't been in the hospital for more than 10 days at VAP diagnosis. Participants must be able to consent or have a representative do so. Excluded are those with septic shock, recent immunosuppressant use, legal incarceration, prior VAP this admission, certain resistant infections, extensive recent antibiotics use, imminent death prognosis, transfer from another facility after 72 hours+, and pregnant or breastfeeding women.Check my eligibility
What is being tested?
The study tests if shorter antibiotic treatment (4 days) is as safe and effective as the standard duration (7 days) for early ventilator-associated pneumonia. The goal is to minimize antibiotic-related side effects without compromising patient safety.See study design
What are the potential side effects?
Potential side effects include typical adverse reactions associated with antibiotics such as allergic reactions, gastrointestinal issues like nausea and diarrhea, potential development of drug-resistant bacteria due to overuse of antibiotics.
DATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for or have had surgery.
Select...
I was in the hospital for less than 10 days when diagnosed with VAP.
DATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Antibiotics
Number of participants with reoccurring VAP
Secondary outcome measures
Amount of antibiotic exposure
Clinical improvement as measured by the Clinical Pulmonary Infection Score
Hospital Length Of Stay
+8 moreDATE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 4 Days of Antibiotics GroupExperimental Treatment1 Intervention
Participants will receive 4 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Group II: 7 Days of Antibiotics GroupActive Control1 Intervention
Participants will receive 7 days of antibiotic therapy administered as per the standard of care for the treatment of early ventilator associated pneumonia (VAP).
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
902 Previous Clinical Trials
409,558 Total Patients Enrolled
Jonathan Meizoso, MD, MSPHPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was hospitalized for more than 72 hours before being transferred.I've been on antibiotics for more than 5 days recently.I have septic shock and need more than one medication to maintain my blood pressure.I am scheduled for or have had surgery.I developed a lung infection within 2-7 days after being put on a breathing machine.You had a previous episode of ventilator-associated pneumonia during this hospital stay.My lung infection is caused by a drug-resistant bacteria.I or my legal representative can give consent for my participation.I have used immunosuppressive medications in the last 30 days.You are very sick and close to passing away.I am under 18 years old.I was in the hospital for less than 10 days when diagnosed with VAP.
Research Study Groups:
This trial has the following groups:- Group 1: 7 Days of Antibiotics Group
- Group 2: 4 Days of Antibiotics Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA sanctioned Standard of Care Antibiotic Therapy?
"There is ample evidence of Standard of Care Antibiotic Therapy's safety, thus its score was set to 3."
Answered by AI
What are the ultimate goals that this experiment seeks to achieve?
"This medical research will evaluate the number of participants with a recurrence of VAP over 30 days and other related metrics, such as: relapse rate due to initial pathogen, in-hospital mortality rates, and prevalence of empyema."
Answered by AI
Is recruitment for this experiment currently available?
"Per clinicaltrials.gov, this trial is no longer accepting patients at the moment - its first posting was on December 15th 2022 and it was edited lastly on September 16th 2022. However, 175 other studies are open to recruitment presently."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger