Recruiting
Phase 2

Antibiotics

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07492134

Conditions

Acute Uncomplicated Diverticulitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

Placebo

Metronidazole

Cefuroxime

Study Details

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

Study ID

NCT07492134

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Apr 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet

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

Placebo

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

Metronidazole

metronidazole: 500 mg every 12 hours

Cefuroxime

cefuroxime: 500 mg every 12 hours

Primary outcome measure

  • Recruitment Rate [ Time Frame: From enrollment through study completion, an average of 2 years. ]
  • Adherence [ Time Frame: From enrollment through study completion, an average of 2 years ]
  • Data completeness [ Time Frame: From enrollment through study completion, an average of 2 years ]
  • Retention [ Time Frame: From enrollment through study completion, an average of 2 years ]
  • Acceptability [ Time Frame: Collected at 14 days and 6 months ]
  • Cross over [ Time Frame: From enrollment through study completion, an average of 2 years ]

Central Contacts and Locations

Locations

Vanderbilt University Medical Center Emergency Department

Recruiting

Nashville, Tennessee, United States, 37235

Contacts

Alexander T Hawkins, MD, MPH

+1 (615)343-4612alex.hawkins@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Acute uncomplicated diverticulitis
  • Antibiotic stewardship
  • Antimicrobial resistance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-07-08.