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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

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

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.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days after appendicitis surgery for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of Infectious/Antibiotic Complications

Number of participant deaths

Awards & Highlights

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.

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.

Do I qualify?Apply below to find out