Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Admitted to the ICU within the last 24 hours, or with a witnessed aspiration event in the last 24 hours while in the ICU
Clinical history consistent with possible aspiration (e.g. cardiac arrest, found unconscious, or with a witnessed aspiration event).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from admission to 30 days, death, or hospital discharge, whichever occurs first
Awards & highlights
Study Summary
This trial is testing whether giving antibiotics right away to ICU patients who may have aspirated can improve outcomes.
Who is the study for?
This trial is for ICU patients who've been admitted in the last 24 hours or had a witnessed aspiration event during that time. They must show signs on chest x-rays or CT scans that match aspiration, like certain lung infiltrates or airway debris, and have a clinical history suggesting possible aspiration.Check my eligibility
What is being tested?
The study tests if giving antibiotics early to ICU patients after an aspiration event can prevent pneumonia and improve outcomes. Antibiotics being tested include Ceftriaxone, Amoxicillin clavulanic acid, Cefepime, Vancomycin, and Levofloxacin.See study design
What are the potential side effects?
Possible side effects of these antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, potential liver enzyme changes with amoxicillin clavulanic acid use, and rarely tendon damage from Levofloxacin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was admitted to the ICU or had a choking incident there within the last day.
Select...
I have a history that suggests I might have inhaled something into my lungs (like during a choking incident).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from admission to 30 days, death, or hospital discharge, whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from admission to 30 days, death, or hospital discharge, whichever occurs first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ICU-free days
Secondary outcome measures
Additional antibiotics prescribed
Antibiotic-free days
Any positive culture with organism resistant to prophylactic antibiotics
+12 moreSide effects data
From 2022 Phase 2 trial • 100 Patients • NCT0348595017%
Febrile neutropenia
13%
Fever
11%
Bloodstream infection
11%
Lung infection
9%
Rash
9%
Catheter related infection
6%
ALT elevation
6%
Urinary tract infection
6%
Infections and infestations
6%
Respiratory failure
4%
Skin infection
4%
Enterocolitis
4%
Shortness of breath
2%
Headache
2%
Bilirubin increased
2%
Small intestinal obstruction
2%
Creatinine increased
2%
Upper respiratory infection
2%
Disease progression
2%
Viral hepatitis
2%
Dehydration
2%
Vascular access complication
2%
Viral infection
2%
Hypernatremia
2%
Hypotension
2%
Chest pain
2%
Hypertension
2%
Encephalopathy
2%
Bacterial infection
2%
Back pain
2%
Atrial fibrillation
2%
Multi-organ failure
2%
Sepsis
2%
Sore throat
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ceftolozane/Tazobactam Arm
Standard of Care (SOC) Arm
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AntibioticsExperimental Treatment5 Interventions
5 days of empiric antibiotics selected from a guideline-appropriate regimen. Alternate agents may be selected by the treating team if allergies or other patient factors mandate, but are still recommended for a 5 day course. Supportive care including oxygen and ventilation can be offered ad libitum.
Options include ceftriaxone, Augmentin, cefepime, vancomycin, levofloxacin.
Group II: ControlActive Control1 Intervention
No initial antibiotic therapy unless clinical picture changes or worsens. Supportive care including oxygen and ventilation can be offered ad libitum.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ceftriaxone
2019
Completed Phase 4
~5020
Amoxicillin clavulanic acid
2008
Completed Phase 4
~1790
Cefepime
2015
Completed Phase 4
~460
Vancomycin
2005
Completed Phase 4
~7930
Levofloxacin
2011
Completed Phase 4
~8180
Find a Location
Who is running the clinical trial?
UConn HealthLead Sponsor
211 Previous Clinical Trials
60,521 Total Patients Enrolled
Brandon OtoStudy DirectorUConn Health, Adult Critical Care
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What risks are associated with Cefepime use?
"The safety of Cefepime has been validated by Phase 4 clinical trials, garnering it a score of 3 on our team's assessment scale."
Answered by AI
What is the enrollment quota for this trial?
"Affirmative. The information hosted on clinicaltrials.gov suggests this clinical trial is actively recruiting patients, having been first posted on November 30th 2021 and most recently updated on December 3rd 2021. 100 participants need to be sourced from one medical centre."
Answered by AI
What indications is Cefepime commonly utilized to treat?
"Cefepime is a frequent choice for treating tonsillitis, as well as cysto-urethritis, abscesses, and staphylococcal infections."
Answered by AI
Are researchers currently recruiting participants for this scientific endeavor?
"That is correct. According to the information posted on clinicaltrials.gov, this medical study began enrolling patients since November 30th 2021 and has been most recently updated on December 3rd 2021. The research team requires 100 individuals from a single location for their trial."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger