Health TrialsbyHealthPanel

Non-antibiotic Management in Acute Uncomplicated Diverticulitis

ConditionAcute Uncomplicated Diverticulitis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMontefiore Medical Center

About this trial

Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as "mild" when there are no serious complications.

For many years, doctors in the United States have treated mild diverticulitis with antibiotics. New studies from Europe suggest that many people with mild diverticulitis may not need antibiotics and can get better with just pain medicines. But this approach has not been tested in the United States, where antibiotics are still the standard treatment.

The goal of this clinical trial is to find out if people with mild diverticulitis can be safely treated at home without antibiotics. The main questions it aims to answer are:

* Are people treated without antibiotics admitted to the hospital more often than people treated with antibiotics? * Do people treated without antibiotics have more emergency room visits, worsening of their disease, or need for surgery?

Researchers will compare two groups of people who come to the emergency department with mild diverticulitis to see if treatment without antibiotics is as safe as treatment with antibiotics.

Participants will:

* Be sent home with pain medicines (ibuprofen and acetaminophen) only, or with pain medicines plus an antibiotic taken by mouth for 7 days * Follow a liquid diet and slowly return to normal food as they feel better * Come back to clinic for a check-up at 1 to 2 weeks * Answer phone calls about their health at 4 weeks, 3 months, and 6 months

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Left-sided diverticulitis, primary or recurrent

Signs of diverticulitis on CT-confirmed Hinchey (0 or 1a based on CT final report)

White Blood Cell (WBC) count <15,000mm^3

Controlled symptoms in the ED (i.e., Pain score <5 on VAS scale, tolerating PO intake, no fever)

Disqualifiers

Signs of complicated diverticulitis on CT with abscess, fistula, free air, Micro perforation, or signs of other diagnosis on CT Abdomen and pelvis

Inflammatory bowel disease

American Society for Anesthesiologists (ASA) physical status classification of >=3

Immunocompromised patient; (i.e., haematological malignancies, AIDS patients with low CD4+ counts, transplantation, chemotherapy, splenectomy, long-term corticosteroid use and genetic disorders such as severe combined immunodeficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Symptomatic treatment (ibuprofen and acetaminophen)

    Drug

    Oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours, taken as needed for pain control for up to 7 days, combined with a liquid diet advancing as tolerated and standardized return precautions. This symptomatic regimen is administered to participants in both study arms.

  • Amoxicillin-clavulanate

    Drug

    Oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, administered to participants in the antibiotic arm who do not have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen.

  • Ciprofloxacin plus metronidazole

    Drug

    Oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days, administered to participants in the antibiotic arm who have a documented or self-reported penicillin or beta-lactam allergy. Administered in addition to the symptomatic treatment regimen as an alternative to amoxicillin/clavulanate.

Treatment groups

556 Participants
are divided into 2 treatment groups
Group A: No-Antibiotic GroupExperimental treatment 1 intervention
Group B: Standard Antibiotic TherapyActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Diverticulitis-related hospitalization rate

Diverticulitis-related hospitalization rate will be summarized as a frequency measure. The number/percentage of participants requiring hospital admission for any cause related to acute diverticulitis or its complications, including disease progression, intractable pain, intolerance to oral intake, abscess formation, perforation, or need for surgical intervention will be summarized by study arm. Hospitalizations unrelated to diverticulitis will not be counted.

Time frame
Up to 6 months after enrollment

Secondary outcomes

1

Emergency Department revisit rate

Emergency department revisit rate will be summarized as a frequency measure. The number/percentage of participants returning to any Emergency Department for symptoms or complications related to acute diverticulitis after the index ED discharge, regardless of whether the revisit results in hospital admission will be summarized by study arm.

Time frame
Up to 6 months after enrollment
2

Progression to complicated diverticulitis

The number/percentage of participants progressing to complicated diverticulitis, defined as modified Hinchey classification stage 1b or higher, documented on repeat CT of the abdomen and pelvis performed during follow-up will be summarized by study arm. The modified Hinchey is a medical staging system that classifies stages of acute diverticulitis as either Stage 0, Stage Ia, Stage Ib, stage II, stage III, or stage IV based on clinical symptoms corroborated by CT imaging, such that higher stages are indicative of increased severity. Findings may include confined pericolic abscess, pelvic or intraabdominal abscess, generalized peritonitis, or fecal peritonitis.

Time frame
Up to 6 months after enrollment
3

Need for surgery

The number/percentage of participants requiring surgical intervention related to acute diverticulitis or its complications, including but not limited to drainage of abscess, Hartmann procedure, sigmoid colectomy, or other operative management during the follow-up period, will be summarized by study arm. The number/percentage of participants requiring urgent and emergent surgical intervention will be summarized/reported independently.

Time frame
Up to 6 months after enrollment
4

Recurrence of acute diverticulitis

Recurrence of acute diverticulitis will be determined by the number/percentage of participants developing a new episode of acute diverticulitis after complete recovery from the index episode. Recurrence is defined operationally per the American Gastroenterological Association as a new episode of acute diverticulitis occurring after full resolution of a prior incident episode, documented by clinical evaluation and/or imaging.

Time frame
Up to 6 months after enrollment

Other outcomes

1

Pain control assessed by Visual Analog Scale

Self-reported pain intensity measured using a 10-point Visual Analog Scale (VAS) where 0 represents no pain and 10 represents the worst imaginable pain, such that higher scores are associated with increased pain intensity. Pain scores will be collected at each follow-up timepoint and summarized by study arm using descriptive statistics.

Time frame
At 1-2 weeks, 4 weeks, 3 months, and 6 months after enrollment
2

Treatment-related adverse events

The number/percentage of participants reporting any adverse event related to study treatment, including but not limited to nausea, vomiting, diarrhea, allergic reactions, Clostridioides difficile infection, medication intolerance, or other side effects will be summarized by study arm. Adverse events will be captured at each follow-up timepoint using a standardized questionnaire.

Time frame
At 1-2 weeks, 4 weeks, 3 months, and 6 months after enrollment
3

Medication adherence

Medication adherence will be assessed by the number/percentage of participants who self-report completing the prescribed medication regimen as indicated. Adherence will be assessed by participant self-report at the 4-week follow-up, including whether the medication was discontinued before completing the full course. The number/percentage of participants will be summarized by study arm.

Time frame
At 4 weeks after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montefiore Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: