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
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.
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
Parallel
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
Drugamoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
Placebo
DrugA placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
Metronidazole
Drugmetronidazole: 500 mg every 12 hours
Cefuroxime
Drugcefuroxime: 500 mg every 12 hours
Recruitment Rate
Patients recruited per week
Adherence
Percent of patients completing the course of antibiotics/placebo
Data completeness
Percentage of participants for whom a complete data set was collected
Retention
Percentage of patients completing all study activities
Barratt Simplified Measure of Social Status (BSMSS)
BSMSS provides an education, occupation, and overall proxy score for socioeconomic status. Scored on a scale of 8-66, with higher scores indicating higher socioeconomic status.
Brief Health Literacy Scale (BHLS)
3-item questionnaire, scored on a scale of 1-5 with 5 being the highest degree of health literacy
Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)
The PROMIS-10 assesses an individual's mental health (four items) and physical health (four items) domains. The total raw scores are translated into standardized T-scores with a mean of 50 and a SD of 10
Diverticulitis quality of life (DV-QOL) instrument
This instrument was designed and validated to measure patient-reported burden of diverticular disease. It is a 17-question survey of patient-reported burden of disease focused on those with uncomplicated diverticular disease. The survey has raw scores 0-68, with higher scores indicating greater impact of diverticulitis on the patient's quality of life. The raw scores are scaled to a 10-point scale.
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Vanderbilt University Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
