APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

Conditions

• Acute Uncomplicated Diverticulitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet — DRUG
  amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
• Placebo — DRUG
  A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
• Metronidazole — DRUG
  metronidazole: 500 mg every 12 hours
• Cefuroxime — DRUG
  cefuroxime: 500 mg every 12 hours

Study Details

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

Key Dates

Start date

Apr 1, 2026

Status verified

Apr 2026

Primary completion

Apr 1, 2028

Completion

Oct 1, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Antibiotic
  The primary antibiotic choice will be amoxicillin-clavulanate (1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours). If the subject has an allergy or contraindication to the primary antibiotic, we will administer cefuroxime \[500 mg\] every 12 hours plus metronidazole \[500 mg\] every 12 hours.
• Experimental: Placebo
  A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days

Primary Outcome Measure

Recruitment Rate [ Time Frame: From enrollment through study completion, an average of 2 years. ]

Locations (1)

Find similar trials in Nashville, TN

Related Studies

• Non-antibiotic Management in Acute Uncomplicated Diverticulitis
  PHASE4 · Not Yet Recruiting · Montefiore Medical Center · The Bronx, New York