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APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
Sponsor: 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
Official title: Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-04-01
Completion Date
2028-10-01
Last Updated
2026-03-25
Healthy Volunteers
No
Conditions
Interventions
Ciprofloxacin
ciprofloxacin: 500 mg every 12 hours
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
Placebo
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
Metronidazole
metronidazole: 500 mg every 8 hours
Locations (1)
Vanderbilt University Medical Center Emergency Department
Nashville, Tennessee, United States