Comparing Placebo Versus Antibiotics for Acute Uncomplicated Diverticulitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Recruitment Rate
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cefuroxime (Drug)
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.
干预措施: Metronidazole (Drug)
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.
干预措施: Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet (Drug)
Placebo
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
Recruitment Rate
时间窗: From enrollment through study completion, an average of 2 years.
Patients recruited per week
Adherence
时间窗: From enrollment through study completion, an average of 2 years
Percent of patients completing the course of antibiotics/placebo
Data completeness
时间窗: From enrollment through study completion, an average of 2 years
Percentage of participants for whom a complete data set was collected
Retention
时间窗: From enrollment through study completion, an average of 2 years
Percentage of patients completing all study activities
Acceptability
时间窗: 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
时间窗: From enrollment through study completion, an average of 2 years
Defined as the number of placebo subjects that ended up being treated with antibiotics
次要结局
- 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)
- Time to normalization of abdominal pain intensity(Collected at enrollment, daily for 30 days, and at 6 months)
- Rate of Progression to Complicated Diverticulitis(Collected at enrollment, 14 days, 30 days, and 6 months)
- Rate of persistent diverticulitis at 30 days(Collected 30 days from enrollment)
- Rate of diverticulitis-related hospitalization, percutaneous drainage and colectomy(From enrollment through study completion, an average of 2 years)
- Mortality(From enrollment through study completion, an average of 2 years)
- Adverse Drug Events(From enrollment through study completion, an average of 2 years)
- Return to normal activity(From enrollment through study completion, an average of 2 years)
- Recurrence(From 8 weeks into the study through study completion, an average of 2 years)
研究者
Alexander Hawkins
Principal Investigator
Vanderbilt University Medical Center