Evaluating short-course antibiotics 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)
This study is testing whether a shorter course of antibiotics after appendicitis surgery is just as safe and effective as the usual longer treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05746520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety, efficacy, and feasibility of reducing the duration of post-operative antibiotic treatment for patients undergoing surgery for appendicitis. It is a single-center, randomized controlled trial that will compare the outcomes of patients receiving a short course of antibiotics versus a standard longer course. The goal is to minimize the risk of adverse effects associated with prolonged antibiotic use while ensuring patient safety. Participants will be monitored for complications and overall recovery.
Who should consider this trial
Good fit: Ideal candidates for this study 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 certain medical conditions such as heart failure or active infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to reduced antibiotic exposure and fewer side effects for patients recovering from appendicitis surgery.
How similar studies have performed: Other studies have explored the impact of antibiotic duration in surgical settings, suggesting potential benefits, but this specific approach is relatively novel.
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 Acquired immunodeficiency syndrome (AIDS) * Heart Failure * Allergy to Bupivacaine * Unlikely to comply with treatment or follow-up * Inpatient consultation for appendicitis * Clinically suspected sepsis based on Sepsis-3 definition * Current use of antibiotics for other indications * Type 1 Diabetes or uncontrolled hyperglycemia
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rafael Torres Fajardo, MD — Wake Forest University Health Sciences
- Study coordinator: Jessica Garcia Lopez
- Email: jessica.garcialopez@atriumhealth.orgg
- Phone: 704-446-8221
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.