Acute Uncomplicated Diverticulitis
Conditions
Keywords
Acute uncomplicated diverticulitis, Antibiotic stewardship, Antimicrobial resistance
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
Interventions
amoxicillin-clavulanate:1 tablet \[875 mg amoxicillin; 125 mg clavulanic acid\] every 8 hours
DRUGPlacebo
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
DRUGMetronidazole
metronidazole: 500 mg every 12 hours
DRUGCefuroxime
cefuroxime: 500 mg every 12 hours
Sponsors
Vanderbilt University Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rate | From enrollment through study completion, an average of 2 years. | Patients recruited per week |
| Adherence | From enrollment through study completion, an average of 2 years | Percent of patients completing the course of antibiotics/placebo |
| Data completeness | From enrollment through study completion, an average of 2 years | Percentage of participants for whom a complete data set was collected |
| Retention | From enrollment through study completion, an average of 2 years | Percentage of patients completing all study activities |
| Acceptability | 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 | From enrollment through study completion, an average of 2 years | Defined as the number of placebo subjects that ended up being treated with antibiotics |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barratt Simplified Measure of Social Status (BSMSS) | Collected at the time of enrollment | BSMSS provides an education, occupation, and overall proxy score for socioeconomic status. Scored on a scale of 8-66, with higher scores indicating higher socioeconomic status. |
| Brief Health Literacy Scale (BHLS) | Collected at enrollment | 3-item questionnaire, scored on a scale of 1-5 with 5 being the highest degree of health literacy |
| Patient-Reported Outcomes Measurement Information System-10 (PROMIS-10) | Collected at the time of enrollment, 30 days, and 6 months | The PROMIS-10 assesses an individual's mental health (four items) and physical health (four items) domains. The total raw scores are translated into standardized T-scores with a mean of 50 and a SD of 10 |
| Diverticulitis quality of life (DV-QOL) instrument | Collected at enrollment, then 14 and 30 days into the study. | This instrument was designed and validated to measure patient-reported burden of diverticular disease. It is a 17-question survey of patient-reported burden of disease focused on those with uncomplicated diverticular disease. The survey has raw scores 0-68, with higher scores indicating greater impact of diverticulitis on the patient's quality of life. The raw scores are scaled to a 10-point scale. |
| Patient-Reported Outcomes Measurement Information System, Gastrointestinal | Collected at enrollment and 14 days into study | 5 item survey that assesses abdominal pain, scored 5-25 with higher scores indicating more severe abdominal pain |
| Time to normalization of abdominal pain intensity | Collected at enrollment, daily for 30 days, and at 6 months | 11-point numerical rating scale (NRS) from 0 (no pain) to 10 (worst possible pain) that asks subjects daily to rate their worst abdominal pain over the past 24-hours |
| Rate of Progression to Complicated Diverticulitis | Collected at enrollment, 14 days, 30 days, and 6 months | Captured via review of the EMR and any follow up CT scans |
| Rate of persistent diverticulitis at 30 days | Collected 30 days from enrollment | DV-QOL scores below the patient acceptable symptom state threshold of 3.2/10 |
| Rate of diverticulitis-related hospitalization, percutaneous drainage and colectomy | From enrollment through study completion, an average of 2 years | Collected from EMR and patient queries |
| Mortality | From enrollment through study completion, an average of 2 years | Obtained from Social Security Administration Death Master File |
| Adverse Drug Events | From enrollment through study completion, an average of 2 years | Including, but not limited to rash, diarrhea, urticaria and anaphylaxis will be captured using self-reported surveys with review of the EMR |
| Return to normal activity | From enrollment through study completion, an average of 2 years | For subjects who currently are employed, the researchers will ask baseline information about past-month work absenteeism (missed work due to health) and presenteeism (impaired work due to health). The subject will complete the validated Work Productivity and Activity Impairment questionnaire. At each follow up period, the researchers will repeat these measures and inquire if they had suffered an adverse work event (firing, demotion) and if they have had to go on any leave. This is a 6- item instrument on a visual analog scale of 0-10. Scores for each item are multiplied by 100 to calculate percentages. The WPAI calculates percentage impairment (maximum 100%) with higher numbers representing greater work impairment. |
| Recurrence | From 8 weeks into the study through study completion, an average of 2 years | CT-proven acute diverticulitis after complete resolution of symptoms more than 2 months after initial evaluation in the ED. This will be captured by review of the EMR and direct patient query |
Countries
United States
Outcome results
None listed