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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
CASA-RELAX Trial 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.Check my eligibility
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.See study design
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.
CASA-RELAX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cure
Infectious/antibiotic complication requiring Emergency Department visit
Infectious/antibiotic complication requiring antibiotic treatment only only or no specific treatment
+4 moreCASA-RELAX 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
338 Previous Clinical Trials
75,934 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have heart failure.I have Type 1 Diabetes or my blood sugar levels are very high and hard to control.I am hospitalized for appendicitis.I have a working phone or reliable way to be contacted after leaving the hospital.I am immunocompromised due to medication, a condition affecting my immune system, or AIDS.I am unable to give consent by myself.I prefer this treatment option.I am suspected to have a severe infection according to the latest criteria.I am currently taking antibiotics for a condition other than cancer.I cannot provide information on the research team's availability.I am 18 years old or older.I am scheduled for an appendectomy.My surgeon has a preferred method for my surgery.
Research Study Groups:
This trial has the following groups:- Group 1: under 65 years simple appendicitis restricted duration
- Group 2: Over 65 complex appendicitis restricted antibiotic duration
- Group 3: Under 65 simple appendicitis liberal duration
- Group 4: Under 65 complex appendicitis restricted duration
- Group 5: Under 65 complex appendicitis liberal duration
- Group 6: Over 65 simple appendicitis restricted antibiotic duration
- Group 7: Over 65 simple appendicitis liberal antibiotic duration
- Group 8: Over 65 appendicitis liberal antibiotic duration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for recruitment in this clinical trial?
"Based on the information available, this clinical trial is actively recruiting. The study was first advertised in January of 2023 and has been edited as recently as April of that same year."
Answered by AI
How many participants are actively engaging in this research project?
"Affirmative. The clinicaltrials.gov website notes that this trial is actively searching for recruits, and was initially posted on the 24th of January 2023 before being updated on the 20th April in the same year. Fifty patients are needed between two sites."
Answered by AI
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