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Antibiotic Duration for Appendicitis (CASA-RELAX Trial)

N/A
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare short vs long antibiotic courses after appendectomy based on appendicitis status. Data will test if shorter courses are non-inferior to longer ones.

Who is the study for?
This trial is for adults (18+) who are about to have their appendix removed due to appendicitis and can give informed consent. They must have a reliable way to be contacted after leaving the hospital.
What is being tested?
The study is testing if shorter antibiotic treatments work just as well as longer ones after appendix surgery. Patients with simple appendicitis will get either peri-operative antibiotics or a 24-hour dose, while those with complex cases will receive either a 24-hour or a four-day course.
What are the potential side effects?
Potential side effects from antibiotics may include allergic reactions, gastrointestinal issues like diarrhea or nausea, and possibly an increased risk of developing antibiotic resistance.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cure

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Active Control
Group I: under 65 years simple appendicitis restricted durationActive Control1 Intervention
simple appendicitis restricted duration of no postop antibiotics
Group II: Over 65 complex appendicitis restricted antibiotic durationActive Control1 Intervention
see above for under 65
Group III: Under 65 simple appendicitis liberal durationActive Control1 Intervention
simple appendicitis liberal duration of 24 hours postop antibiotics
Group IV: Under 65 complex appendicitis restricted durationActive Control1 Intervention
complex appendicitis restricted duration of 24 hours postop antibiotics
Group V: Under 65 complex appendicitis liberal durationActive Control1 Intervention
complex appendicitis liberal duration of 4 days of postop antibiotics
Group VI: Over 65 simple appendicitis restricted antibiotic durationActive Control1 Intervention
see above for under 65
Group VII: Over 65 simple appendicitis liberal antibiotic durationActive Control1 Intervention
see above for under 65
Group VIII: Over 65 appendicitis liberal antibiotic durationActive Control1 Intervention
see above for under 65

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
347 Previous Clinical Trials
77,551 Total Patients Enrolled

Media Library

under 65 years simple appendicitis restricted duration Clinical Trial Eligibility Overview. Trial Name: NCT05838248 — N/A
Acute Appendicitis Research Study Groups: under 65 years simple appendicitis restricted duration, Over 65 complex appendicitis restricted antibiotic duration, Under 65 simple appendicitis liberal duration, Under 65 complex appendicitis restricted duration, Under 65 complex appendicitis liberal duration, Over 65 simple appendicitis restricted antibiotic duration, Over 65 simple appendicitis liberal antibiotic duration, Over 65 appendicitis liberal antibiotic duration
Acute Appendicitis Clinical Trial 2023: under 65 years simple appendicitis restricted duration Highlights & Side Effects. Trial Name: NCT05838248 — N/A
under 65 years simple appendicitis restricted duration 2023 Treatment Timeline for Medical Study. Trial Name: NCT05838248 — N/A
~22 spots leftby Jun 2026
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