Outpatient Treatment Without Antibiotics or with Ciprofloxacin, Cefuroxime, Cefditoren Pivoxil, Amoxicillin/Clavulanic Acid, and Metronidazole in Adults with Acute Uncomplicated Diverticulitis

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What is this study about?

This clinical trial is studying acute uncomplicated diverticulitis, a condition in which small pouches in the bowel become inflamed, without signs of a more serious infection. The purpose of the study is to compare outpatient treatment without antibiotics with outpatient treatment using antibiotics.

The treatments being studied are oral tablets of metronidazole, amoxicillin/clavulanic acid, cefditoren pivoxil, ciprofloxacin, and cefuroxime. These are medicines taken by mouth that are commonly used to treat bacterial infections. The study looks at whether people can be treated safely without antibiotics or whether antibiotic treatment works better in this condition.

People in the study receive outpatient care, meaning treatment without staying in the hospital. The course of the study includes starting treatment and then follow-up over time to see how the condition improves or returns. The study also checks for any later episodes of diverticulitis and how quickly normal daily activities are resumed. The trial is being carried out at several centers.

1 start of the trial

diverticulitis is the condition studied in this trial. uncomplicated acute diverticulitis means a sudden flare-up of diverticulitis that is not described as having complications.

At the start of the trial, you are assigned to one of two treatment groups: treatment without antibiotics or treatment with antibiotics.

2 treatment without antibiotics

If you are assigned to the group without antibiotics, you receive outpatient treatment without antibiotic medicine.

The source information does not give a dose, frequency, or duration for this group.

3 treatment with antibiotics

If you are assigned to the group with antibiotics, you receive outpatient treatment using oral medicine, which means medicine taken by mouth.

The medicines listed for this group are metronidazole 500 mg, amoxicillin/clavulanic acid 2625 mg, cefditoren pivoxil 400 mg, ciprofloxacin 2250 mg, cefuroxime 500 mg, and ciprofloxacin 1000 mg.

The source information does not provide the frequency or duration of administration for these medicines.

4 early follow-up

Your progress is checked for therapeutic failure, which means that the treatment does not work as expected.

This check is done early, within 48 hours or less after treatment begins.

5 one-month follow-up

Your progress is checked again at one month after treatment begins.

At this stage, the trial assesses whether there has been therapeutic failure and whether diverticulitis has returned.

6 later trial assessment

The trial also records how long it takes for you to recover, in days, and how long it takes for you to return to normal daily social and work life.

The trial also reviews the number of recurrences, the type of recurrence, the time when recurrence starts, and factors that may predict a poor outcome or a move to complicated acute diverticulitis.

The trial also measures quality of life and satisfaction with the care received.

Who Can Join the Study?

Be over 18 years old.
Have a clinical diagnosis, meaning the doctor’s examination and symptoms show the condition, of uncomplicated acute diverticulitis in the sigmoid colon or descending colon on the left side of the abdomen.
Have a radiological diagnosis, meaning the condition is confirmed by an imaging test, of acute uncomplicated diverticulitis on a CT scan (a detailed X-ray test that creates pictures of the inside of the body).
Have a CT scan result that matches modified Hinchey classification 0-Ia, which means the inflammation is mild and there is no complicated infection.
Have either a first episode of diverticulitis or a previous history of diverticulitis, whether it was complicated or uncomplicated, as long as at least 6 months have passed since the last episode before the current clinic visit.
Be willing to sign the informed consent form, which means the patient agrees to take part after understanding the study.

Who Cannot Join the Study?

Being older than 70 years.
Having signs that make hospital treatment necessary instead of outpatient treatment, such as repeated vomiting, not being able to keep down food or drink, needing intravenous fluids (fluids given through a vein), needing close medical monitoring, having a temperature above 38°C, getting worse overall, or having a medical concern for sepsis (a serious body-wide reaction to infection).
Having a serious illness that is not well controlled, called decompensated comorbidity, or being classified as ASA IV (this means a very severe general health condition).
Having a weakened immune system, including blood-related causes, HIV with low CD4+ levels (a type of immune cell), treatment that suppresses the immune system, long-term corticosteroid use (steroid medicines), chemotherapy, having had an organ transplant, having had the spleen removed, or having certain genetic immune disorders such as severe combined immunodeficiency.
Having taken antibiotics by mouth or through a vein in the 2 weeks before the symptoms started, for a different reason.
Being pregnant.
Having inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis.
Not having enough social support to make outpatient treatment possible, meaning there is no practical help at home or in daily life to safely follow the treatment plan.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital General Universitario Morales Meseguer	Murcia	Spain
Hospital Universitario De Getafe	Getafe	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Obispo Polanco	Teruel	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.03.2026

Trial locations

Investigated drugs:

Metronidazole is an antibiotic taken by mouth. In this trial, it is one of the medicines used to treat the infection and inflammation linked to uncomplicated acute diverticulitis.

Amoxicillin and clavulanic acid is an antibiotic treatment taken by mouth. It combines two medicines that work together to fight bacteria, and it is used in this trial as one of the antibiotic treatment options for diverticulitis.

Cefditoren pivoxil is an antibiotic taken by mouth. In this trial, it is used as another treatment option to help fight the bacteria involved in diverticulitis.

Ciprofloxacin is an antibiotic taken by mouth. In this trial, it is used to treat the infection as part of the antibiotic treatment group for diverticulitis.

Cefuroxime is an antibiotic taken by mouth. In this trial, it is used as one of the medicines chosen to treat diverticulitis in the antibiotic treatment group.

Investigated diseases:

Diverticulitis

Diverticular disease of the intestine – Diverticular disease of the intestine is a condition in which small pouches form in the wall of the intestine, most often in the large intestine. It may remain mild for long periods or progress to inflammation when one or more pouches become irritated or infected, causing acute diverticulitis. Over time, some people have repeated episodes, and the condition can sometimes become more severe with ongoing inflammation.

Trial ID:

2025-523121-17-00

Protocol code:

IMIB-ADI-2025-01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Outpatient Treatment Without Antibiotics or with Ciprofloxacin, Cefuroxime, Cefditoren Pivoxil, Amoxicillin/Clavulanic Acid, and Metronidazole in Adults with Acute Uncomplicated Diverticulitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?