NCT07492134 · Vanderbilt University Medical Center
APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
What this study is about
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 effectiveness trial of antibiotics vs.
View original scientific description
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.
Interventions
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 12 hours
DRUG
Cefuroxime
cefuroxime: 500 mg every 12 hours
Primary outcome measures
Recruitment Rate
Time frame: From enrollment through study completion, an average of 2 years.
Patients recruited per week
Adherence
Time frame: From enrollment through study completion, an average of 2 years
Percent of patients completing the course of antibiotics/placebo
Data completeness
Time frame: From enrollment through study completion, an average of 2 years
Percentage of participants for whom a complete data set was collected
Retention
Time frame: From enrollment through study completion, an average of 2 years
Percentage of patients completing all study activities
Acceptability
Time frame: Collected at 14 days and 6 months
Measured by the Acceptability of Intervention Measure (AIM). Four-question survey with scores ranging from 4 (least acceptable) to 20 (most acceptable).
Cross over
Time frame: From enrollment through study completion, an average of 2 years
Defined as the number of placebo subjects that ended up being treated with antibiotics
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients presenting to the emergency department with left-sided uncomplicated diverticulitis
- Radiologic score (moderate diverticulitis per Ambrosetti classification)
- Access to a smartphone with internet access.
Exclusion criteria
- 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
Where
- Nashville, Tennessee
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations