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NCT05094154 · ClinicalTrials.gov registry record · Phase 4
Effect of Antibiotic Choice On ReNal Outcomes (ACORN)
A Phase 4 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,634
- Enrollment target
NCT05094154 is a Phase 4 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 2,634 participants.
The verdict
NCT05094154, a Phase 4 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,634 participants
- Enrollment target
Study 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.
Interventions
- DRUG anti-pseudomonal cephalosporin
- DRUG anti-pseudomonal penicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,634 participants |
| Start Date | 2021-11-10 |
| Est. Completion | 2022-10-21 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05094154
The ClinicalTrials.gov registry entry for NCT05094154 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,634 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which anti-pseudomonal cephalosporin is the first listed.
NCT05094154 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05094154 about?
NCT05094154 is a clinical study titled "Effect of Antibiotic Choice On ReNal Outcomes (ACORN)". 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 c...
What is the current status of trial NCT05094154?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,634 participants. The study started on 2021-11-10. Estimated completion is 2022-10-21.
What interventions are being tested in trial NCT05094154?
The interventions under investigation include: anti-pseudomonal cephalosporin (DRUG), anti-pseudomonal penicillin (DRUG).
Who is sponsoring clinical trial NCT05094154?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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