APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)

NCT07492134 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2513981R01DK141523-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Acute uncomplicated diverticulitis; Antibiotic stewardship; Antimicrobial resistance

Outcome Measures

Primary Outcomes (6)

• Recruitment Rate

  Patients recruited per week

  From enrollment through study completion, an average of 2 years.

• Adherence

  Percent of patients completing the course of antibiotics/placebo

  From enrollment through study completion, an average of 2 years

• Data completeness

  Percentage of participants for whom a complete data set was collected

  From enrollment through study completion, an average of 2 years

• Retention

  Percentage of patients completing all study activities

  From enrollment through study completion, an average of 2 years

• Acceptability

  Measured by the Acceptability of Intervention Measure (AIM). Four-question survey with scores ranging from 4 (least acceptable) to 20 (most acceptable).

  Collected at 14 days and 6 months

• Cross over

  Defined as the number of placebo subjects that ended up being treated with antibiotics

  From enrollment through study completion, an average of 2 years

Secondary Outcomes (13)

• Barratt Simplified Measure of Social Status (BSMSS)

  Collected at the time of enrollment

• Brief Health Literacy Scale (BHLS)

  Collected at enrollment

• Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10)

  Collected at the time of enrollment, 30 days, and 6 months

• Diverticulitis quality of life (DV-QOL) instrument

  Collected at enrollment, then 14 and 30 days into the study.

• Patient-Reported Outcomes Measurement Information System, Gastrointestinal

  Collected at enrollment and 14 days into study

Study Arms (2)

Antibiotic

ACTIVE COMPARATOR

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.

Drug: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet; Drug: Metronidazole; Drug: Cefuroxime

Placebo

EXPERIMENTAL

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

Drug: Placebo

Interventions

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet DRUG

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

Antibiotic

Placebo DRUG

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

Placebo

Metronidazole DRUG

metronidazole: 500 mg every 12 hours

Antibiotic

Cefuroxime DRUG

cefuroxime: 500 mg every 12 hours

Antibiotic

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Concurrent IBD Diagnosis
• Any other disease process with life expectancy \< 6 months
• Concurrent chronic pain diagnosis.
• Women in pregnancy or breastfeeding
• Antibiotic treatment for any reason in the last 3 weeks
• Diagnosis of prior episode of acute diverticulitis in the past 3 months
• Significant comorbidities: diabetes mellitus with organic involvement (retinopathy, angiopathy, nephropathy), emergency assistance for a cardiogenic event in the last 3 months (acute myocardial infarction, angina, heart failure), decompensation of chronic liver disease in the last 3 months (Child ≥ B) and end-stage renal disease.
• Immunodepression: the absence, and immunodepression is the presence, of any of the following: active neoplastic disease, hematologic malignancy, human immunodeficiency virus long-term corticosteroid treatment, immunosuppressant therapy (20mg pred (or equivalent) for \>2 weeks), transplant, splenectomy and genetic immunodeficiency
• Previous colectomy
• Patients with dementia, memory disorders or other cognitive impairment that would impact their ability to provide informed consent or otherwise participate in the trial

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Vanderbilt University Medical Center Emergency Department

Nashville, Tennessee, 37235, United States

Location

Related Publications (21)

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MeSH Terms

Interventions

Amoxicillin-Potassium Clavulanate Combination; Metronidazole; Cefuroxime

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Cephalosporins; Thiazines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (1)