Phase 4
N=2,634
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
Sepsis · AKI · Neurotoxicity
Bottom Line
View on ClinicalTrials.gov: NCT05094154 ↗Enrolled (actual)
2,634
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Acute Kidney Injury (AKI) Ordinal Scale — 910; 952; 86; 100 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- anti-pseudomonal cephalosporin (Drug); anti-pseudomonal penicillin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt University Medical Center
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Kidney Injury (AKI) Ordinal Scale |
910; 952; 86; 100; 41; 70 | — |
| SECONDARY Major Adverse Kidney Events Within 14 Days (MAKE14) |
124; 114 | — |
| SECONDARY Delirium and Coma-Free Days to Day 14 |
14; 14 | — |
Summary
Sepsis is one of the most common causes of acute illness and death in the United States. Early, empiric broad-spectrum antibiotics are a mainstay of sepsis treatment. Two classes of antibiotics with activity against Pseudomonas, anti-pseudomonal cephalosporins and anti-pseudomonal penicillins, are commonly used for acutely ill adults with sepsis in current practice. Recent observational studies, however, have raised concern that anti-pseudomonal penicillins may cause renal toxicity. Anti-pseudomonal cephalosporins, by comparison, may be associated with a risk of neurotoxicity. Rigorous, prospective data regarding the comparative effectiveness and toxicity of these two classes of medications among acutely ill patients are lacking. The investigator propose a randomized trial comparing the impact of anti-pseudomonal cephalosporins and anti-pseudomonal penicillins on renal outcomes of acutely ill patients.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years old
- Located in a participating emergency department or medical intensive care unit
- Less than 12 hours from presentation to study hospital
- Treating clinician initiating an order for an anti-pseudomonal cephalosporin or anti-pseudomonal penicillin
Exclusion Criteria
- Known receipt of > 1 dose of an anti-pseudomonal cephalosporin or anti-pseudomonal penicillin during the last 7 days
- Current documented allergy to cephalosporins or penicillin
- Known to be a prisoner
- Treating clinicians feel that either an anti-pseudomonal cephalosporin or anti-pseudomonal penicillin is required or contraindicated for the optimal treatment of the patient, including for more directed antibiotic therapy against known prior resistant infections or suspected sepsis with an associated central nervous system infection
Data sourced from ClinicalTrials.gov (NCT05094154). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.