NCT07492134

APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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

Conditions

• Acute Uncomplicated Diverticulitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-04-01
• Completion: 2028-10-01
• First posted: 2026-03-25
• Last updated: 2026-03-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study