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APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

StatusRecruiting
PhasePhase 2
Started2026-07-07
View on ClinicalTrials.gov ↗

Amendment history

2026-07-07
Study Status, Contacts/Locations v2
Recruitment opened
Start date2026-04-01→2026-07-07
Study sitesdetails revised at 1 of 1 site
2026-04-15
Study Status, Arms and Interventions v1
InterventionsAmoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (Drug), Ciprofloxacin (Drug), Metronidazole (Drug), Placebo (Drug)→Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (Drug), Cefuroxime (Drug), Metronidazole (Drug), Placebo (Drug)
2026-03-18
Original filing
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
Trial Details
NCT Number NCT07492134
Lead Sponsor Vanderbilt University Medical Center
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Acute Uncomplicated Diverticulitis
Enrollment 100 participants
Start Date 2026-07-07
Primary Completion 2028-04-01 (estimated)
Study Completion 2028-10-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-21