Comparing short and long antibiotic treatments after appendectomy
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)
This study is testing whether shorter courses of antibiotics after appendectomy are just as effective as longer ones in preventing complications for people with different types of appendicitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT05838248 on ClinicalTrials.gov |
What this trial studies
This prospective trial randomizes patients who have undergone an appendectomy into two groups based on the complexity of their appendicitis. For those with simple appendicitis, they will receive either peri-operative antibiotics or a 24-hour course, while those with complex appendicitis will be assigned to either a 24-hour or a 4-day antibiotic regimen. The study aims to determine if shorter antibiotic durations are as effective as longer ones in preventing complications. Data will be collected prospectively, and advanced matching techniques will be used to ensure valid comparisons between treatment groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for an appendectomy and can provide informed consent.
Not a fit: Patients who are immunocompromised, pregnant, or have other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced antibiotic use and lower rates of antibiotic resistance in patients undergoing appendectomy.
How similar studies have performed: Other studies have shown promising results with shorter antibiotic courses in similar surgical contexts, suggesting this approach may be viable.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Planned appendectomy (laparoscopic or open) * Willing and able to provide informed consent * 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
Louisville, Kentucky and 1 other locations
- Jewish Hospital UL — Louisville, Kentucky, United States (Recruiting)
- University of Louisville Hospital — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: William G Cheadle, MD
- Email: wg.cheadle@louisville.edu
- Phone: 5028525675
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.