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NOT YET RECRUITING
NCT07492134
PHASE2

APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

Interventions

DRUG

Ciprofloxacin

ciprofloxacin: 500 mg every 12 hours

DRUG

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours

DRUG

Placebo

A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days

DRUG

Metronidazole

metronidazole: 500 mg every 8 hours

Locations (1)

Vanderbilt University Medical Center Emergency Department

Nashville, Tennessee, United States