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Antibiotics for Appendicitis (CASA RELAX Trial)
Phase 4
Recruiting
Led By Lucy Kornblith, MD
Research Sponsored by University of California, San Francisco
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 up to 30 days after appendicitis surgery
Awards & highlights
CASA RELAX Trial Summary
This trial shows antibiotics can be used to treat appendicitis, reducing the need for surgery and its complications.
Who is the study for?
Adults over 18 with appendicitis who are undergoing an appendectomy and can be contacted post-surgery. Excluded are those with Type 1 Diabetes or uncontrolled sugar levels, immune system issues due to medications or conditions like AIDS, allergies to bupivacaine, heart failure, suspected sepsis, current antibiotic use for other reasons, or if they're unlikely to follow the study plan.Check my eligibility
What is being tested?
The trial is testing whether a short course of various standard antibiotics after surgery is safe and effective for treating simple and complicated appendicitis. The exact antibiotics used are chosen by the doctors involved in the case.See study design
What are the potential side effects?
Potential side effects from the antibiotics may include allergic reactions, gastrointestinal symptoms like nausea or diarrhea, potential development of resistance if bacteria survive treatment courses, and less commonly blood disorders.
CASA RELAX Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days after appendicitis surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days after appendicitis surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Infectious/Antibiotic Complications
Number of participant deaths
CASA RELAX Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Restricted Post-Operative Antibiotics GroupExperimental Treatment1 Intervention
Participants undergoing standard of care (SOC) with simple appendicitis will not receive post-operative antibiotics.
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive up to 24 hours of SOC post-operative antibiotics.
Group II: Liberal Post-Operative Antibiotics GroupActive Control1 Intervention
Participants undergoing standard of care with simple appendicitis will receive 24 hours of post-operative SOC antibiotics
Participants undergoing standard of care with complicated (gangrenous or perforated) appendicitis will receive 4 days of post-operative SOC antibiotics.
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Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,507 Previous Clinical Trials
15,238,428 Total Patients Enrolled
1 Trials studying Appendicitis
75 Patients Enrolled for Appendicitis
Lucy Kornblith, MDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
367 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My surgeon has a preferred method for my surgery.I prefer this treatment option.I have heart failure.I am currently taking antibiotics for a condition other than cancer.I am scheduled for an appendectomy.I am unable to give consent by myself.I am hospitalized for appendicitis.I am 18 years old or older.I am suspected to have sepsis according to the latest criteria.I have Type 1 Diabetes or my blood sugar levels are very high and hard to control.I have a working phone or reliable way to be contacted after leaving the hospital.I am immunocompromised due to medication, a condition, or treatment I am receiving.
Research Study Groups:
This trial has the following groups:- Group 1: Restricted Post-Operative Antibiotics Group
- Group 2: Liberal Post-Operative Antibiotics Group
Awards:
This trial has 3 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
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.
Could you elucidate the risks associated with Restricted Post-Operative Antibiotics Group?
"There is considerable research backing the safety of Restricted Post-Operative Antibiotics Group, thus it scored a 3 on our scale. As this treatment has been approved by regulatory bodies, it meets Phase 4 criteria."
Answered by AI
Are participants still being accepted for this clinical study?
"Affirmative. According to details available on clinicaltrials.gov, this medical trial went live on June 6th 2023 and is now in the process of recruiting candidates. A total of 145 volunteers need to be enrolled from a single centre."
Answered by AI
How many subjects are being observed for this clinical experiment?
"Affirmative. As per the clinicaltrials.gov data, this medical experiment is currently looking for volunteers to participate in it. The trial was first posted on June 6th 2023 and amended most recently on July 25th 2023. It intends to recruit 145 individuals across a single site of implementation."
Answered by AI
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