CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 2,634 enrolled
Drug / intervention
anti-pseudomonal cephalosporin +1 moredrug
Likely dose
anti-pseudomonal cephalosporin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05094154
NCT05094154Phase 4Completed

Effect of Antibiotic Choice On ReNal Outcomes (ACORN)

Vanderbilt University Medical Center·interventional·Posted Oct 26, 2021·Updated Dec 22, 2023

In Brief

A Phase 4 clinical trial evaluating anti-pseudomonal cephalosporin and anti-pseudomonal penicillin for Sepsis and 2 related conditions. Completed, enrolled 2,634 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedOct 26, 2021
Enrollment StartNov 10, 2021
Primary CompletionOct 21, 2022
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.7 years ago

Interventions

anti-pseudomonal cephalosporindrug

Providers will be prompted to order an anti-pseudomonal cephalosporin, such as cefepime with a dose range of 500 mg, 1,000 mg, or 2,000 mg, and frequency every 6, 8, 12, or 24 hours based on provider discretion.

anti-pseudomonal penicillindrug

Providers will be prompted to order anti-pseudomonal penicillin, such as piperacillin-tazobactam with a dose range of 3.375 g or 4.5 g and frequency every 6, 8, or 12 hours based on provider discretion.