APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorVanderbilt University Medical Center

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
  • Placebo
  • Metronidazole
  • Cefuroxime

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vanderbilt University Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator