Evaluating antibiotic use after appendicitis surgery
Complex And Simple Appendicitis: REstrictive or Liberal Post-operative Antibiotic eXposure (CASA RELAX) Using Desirability of Outcome Ranking (DOOR) and Response Adjusted for Duration of Antibiotic Risk (RADAR) -A Randomized Controlled Trial
PHASE4 · University of California, San Francisco · NCT05966454
This study is testing whether a shorter course of antibiotics after appendicitis surgery is safe and effective for patients compared to the usual longer treatment.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 145 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT05966454 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, efficacy, and feasibility of a shorter course of post-operative antibiotics for patients undergoing surgery for appendicitis. It is a single-center, randomized controlled trial that will compare standard antibiotic treatment durations to determine if reducing antibiotic exposure can minimize adverse effects while maintaining patient safety. Participants will be monitored for outcomes related to their recovery and any complications that may arise from the differing antibiotic regimens.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are scheduled for an appendectomy.
Not a fit: Patients who are immunocompromised, pregnant, or have certain medical conditions such as heart failure or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced antibiotic exposure for patients, minimizing side effects while ensuring effective treatment.
How similar studies have performed: Other studies have explored antibiotic use in appendicitis treatment, but this specific approach to reducing post-operative antibiotic exposure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age ≥ 18 years * Age ≥ 18 years * Planned appendectomy (laparoscopic or open) * Working telephone number or reliable method to contact patient after hospital discharge Exclusion Criteria: * Unable to consent * Pregnant Women * Prisoners * Immunocompromised as determined by clinical team, or patients actively receiving steroids, chemotherapy, or immunosuppressing medications (for example tacrolimus), or patients with active hematologic malignancy affecting the immune system, leukopenia, or end-stage AIDS * Heart failure * Allergy to bupivacaine * Unlikely to comply with treatment or follow-up * Inpatient consultation for appendicitis * Clinically suspected of sepsis based on Sepsis-3 definition * Current use of antibiotics for other indications * Type 1 Diabetes or uncontrolled hyperglycemia * Surgeon preference * Patient preference * Research team unavailable
Where this trial is running
San Francisco, California
- Zuckerberg San Francisco General Hospital — San Francisco, California, United States (RECRUITING)
Study contacts
- Principal investigator: Lucy Kornblith, MD — University of California, San Francisco
- Study coordinator: Lucy Kornblith, MD
- Email: Lucy.Kornblith@ucsf.edu
- Phone: 628-206-6946
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Appendicitis