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Antibiotic
Early Antibiotics for Pneumonia
Phase 4
Waitlist Available
Research Sponsored by UConn Health
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 between admission to 30 days, death, or hospital discharge, whichever occurs first
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved
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.
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.
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 ~ between admission to 30 days, death, or hospital discharge, whichever occurs first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between admission to 30 days, death, or hospital discharge, whichever occurs first
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Additional antibiotics prescribed
Any positive culture with organism resistant to prophylactic antibiotics
Arterial oxygen saturation / Fraction of inspired oxygen (S/F) <215 on day 3
+9 moreSide effects data
From 2022 Phase 2 trial • 100 Patients • NCT0348595017%
Febrile neutropenia
13%
Fever
11%
Bloodstream infection
11%
Lung infection
9%
Catheter related infection
9%
Rash
6%
ALT elevation
6%
Infections and infestations
6%
Urinary tract infection
6%
Respiratory failure
4%
Enterocolitis
4%
Skin infection
4%
Shortness of breath
2%
Chest pain
2%
Creatinine increased
2%
Encephalopathy
2%
Headache
2%
Bilirubin increased
2%
Disease progression
2%
Small intestinal obstruction
2%
Dehydration
2%
Hypernatremia
2%
Hypertension
2%
Hypotension
2%
Upper respiratory infection
2%
Viral infection
2%
Vascular access complication
2%
Viral hepatitis
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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
~9340
Amoxicillin clavulanic acid
2008
Completed Phase 4
~1790
Cefepime
2015
Completed Phase 4
~460
Vancomycin
2020
Completed Phase 4
~7920
Levofloxacin
2011
Completed Phase 4
~8180
Find a Location
Who is running the clinical trial?
UConn HealthLead Sponsor
214 Previous Clinical Trials
60,626 Total Patients Enrolled
Brandon OtoStudy DirectorUConn Health, Adult Critical Care