Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
Vanderbilt University Medical Center
Summary
The goal of this clinical trial is to determine whether antibiotics improve recovery from acute uncomplicated diverticulitis (AUD) in racially and ethnically diverse United States clinical practice. The main questions it seeks to answer are: * What is the feasibility for completing a subsequent definitive efficacy trial of antibiotics vs. placebo to treat AUD? * What are the needs for successful recruitment of racial and ethnic subgroups? * What are the effects of a placebo compared to antibiotics for AUD on a range of key patient-centric efficacy and safety endpoints? * How do such effects differ by race and ethnicity? Researchers will compare a placebo to antibiotics to see if AUD can be treated without using antibiotics. Participants will: * Take two antibiotics or a matching placebo every day for 10 days * Receive analgesia, gastric protection, diet modifications, and a follow-up * Submit daily photos of pills to the study team to verify adherence
Eligibility
- Age range
- 18–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients presenting to the emergency department with left-sided uncomplicated diverticulitis * Radiologic score (moderate diverticulitis per Ambrosetti classification) * Age 18-90 * Access to a smartphone with internet access. Exclusion Criteria: * Complicated diverticulitis (abscess, free air, peritonitis)- severe diverticulitis by Ambrosetti classification * Diverticulitis other than left colon * Contraindication to use of study medication (ie advanced renal failure or allergy to all antibiotics used in the study) * Concurrent cancer diagnosis * Concurrent IBD Diagno…
Interventions
- DrugAmoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
- DrugPlacebo
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
- DrugMetronidazole
metronidazole: 500 mg every 12 hours
- DrugCefuroxime
cefuroxime: 500 mg every 12 hours
Location
- Vanderbilt University Medical Center Emergency DepartmentNashville, Tennessee