Antibiotics for Diverticulitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether antibiotics can aid recovery from acute uncomplicated diverticulitis (AUD), a condition that causes inflammation in the digestive tract. Participants will take either antibiotics (such as Amoxicillin-Clavulanate, Cefuroxime, or Metronidazole) or a placebo for 10 days to determine the necessity of antibiotics for treatment. The study also aims to understand how these treatments affect people of different races and ethnicities. It suits those who have recently visited the emergency room with left-sided uncomplicated diverticulitis and have a smartphone with internet access. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage findings.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that amoxicillin-clavulanate is a well-tolerated option for treating diverticulitis. Research suggests it might lower the risk of serious side effects compared to antibiotics in the fluoroquinolone family. Specifically, the risk of developing a serious gut infection called Clostridioides difficile is lower with amoxicillin-clavulanate.
Another treatment option, the combination of cefuroxime and metronidazole, is also considered safe for treating diverticulitis. Studies show that this combination effectively manages the condition, with no reports of major safety issues when used together.
Both treatment options have been used safely in medical settings, indicating they are well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these antibiotic treatments for diverticulitis because they offer a tailored approach depending on individual patient needs. Unlike the standard of care, which often involves a more generalized use of antibiotics, this treatment plan uses amoxicillin-clavulanate as the primary choice, which combines two active ingredients to target a broader range of bacteria. For patients with allergies or other contraindications to the primary antibiotic, the combination of cefuroxime and metronidazole is used, offering an effective alternative. This flexibility in treatment options could lead to more personalized and effective management of the condition.
What evidence suggests that this trial's treatments could be effective for diverticulitis?
Research has shown that antibiotics like amoxicillin-clavulanate, which participants in this trial may receive, can effectively treat diverticulitis. Studies have found that this antibiotic reduces the risk of certain side effects compared to other antibiotics, without worsening the condition. Another option in this trial is cefuroxime with metronidazole, used to treat bacterial infections, although data specifically for diverticulitis remains less clear. Overall, antibiotics are often used for uncomplicated diverticulitis, but their benefits can vary. Participants in this trial may also receive a placebo to compare the effectiveness of these treatments.12567
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take two antibiotics or a matching placebo every day for 10 days, receive analgesia, gastric protection, diet modifications, and submit daily photos of pills to verify adherence
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recurrence of diverticulitis and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Amoxicillin-Clavulanate
- Cefuroxime
- Metronidazole
- Placebo
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
A placebo matching the antibiotic arm's treatment regimen will be administered for 10 days
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Comparative Effectiveness and Harms of Antibiotics for ... - PMC
Treating diverticulitis in the outpatient setting with amoxicillin-clavulanate may reduce the risk of fluoroquinolone-related harms without adversely impacting ...
Amoxicillin-clavulanate appears safe, effective for ...
The primary outcome measures were one-year risks for inpatient admission, urgent surgery, and Clostridioides difficile infection (CDI) and three ...
Outcome variation in the use and duration of antibiotic therapy ...
While antibiotic-sparing approaches in select patients are supported by high quality data, up to 24% experience treatment failure. Here we ...
4.
gastroenterologyadvisor.com
gastroenterologyadvisor.com/news/diverticulitis-amoxicillin-clavulanate-vs-metronidazole-with-fluoroquinolone/Diverticulitis: Amoxicillin-Clavulanate vs Metronidazole- ...
Treating patients with diverticulitis with amoxicillin-clavulanate is as effective as metronidazole-with-fluoroquinolone.
5.
2minutemedicine.com
2minutemedicine.com/amoxicillin-clavulanate-offers-similar-effectiveness-for-treating-outpatient-diverticulitis-than-metronidazole-with-fluoroquinolone/Amoxicillin-clavulanate offers similar effectiveness for ...
Treatment of outpatient diverticulitis with amoxicillin-clavulanate was shown to be comparably effective as a treatment of metronidazole-with- ...
6.
uspharmacist.com
uspharmacist.com/article/amoxicillinclavulanate-might-be-safer-option-for-uncomplicated-diverticulitisAmoxicillin-Clavulanate Might Be Safer Option for ...
Amoxicillin-clavulanate might be prescribed instead of metronidazole-with-fluoroquinolone to reduce the risk for serious harms associated with fluoroquinolone ...
Protective effects of amoxicillin and probiotics on colon ... - PMC
In this study, we showed that amoxicillin (especially together with probiotics) had protective effects against DSS/LPS-induced acute diverticulitis. DSS induces ...
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