BridgeMD
Compares treatment options for Acute Uncomplicated Diverticulitis
Official title APLAUD Trial (Antibiotics vs PLacebo for Acute Uncomplicated Diverticulitis)
ClinicalTrials.gov ID: NCT07492134
What this study is testing
What is Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet?
Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute uncomplicated diverticulitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join 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 likely can't join 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
See the full eligibility 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.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Nashville, Tennessee, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.