Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis

Study Overview
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Brief Summary
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Medical treatment of uncomplicated acute diverticulitis is not standardized and there is an enormous diversity in clinical practice. The investigators' aim was to demonstrate that uncomplicated diverticulitis can be managed with oral amoxicillin plus clavulanic acid with a short hospital admission.

Detailed Description
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A prospective randomized trial was established to compare patients with uncomplicated diverticulitis who received oral antibiotic after a short course of intravenous antibiotic, with those who received intravenous antibiotic for a longer period. We included 50 patients, 25 in each group. Patients in group 1 begun oral antibiotic as soon as they improved and were discharged the day after. Patients in group 2 received intravenous antibiotic for 7 days. Both groups received oral antibiotic at discharge. The endpoint of the study was failure of treatment which was defined as the impossibility of discharging on the expected day, emergency admission or hospital readmission.

Official Title
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Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis

Conditions
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Diverticulitis

Intervention / Treatment
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* Drug: amoxicillin plus clavulanic acid
* Drug: amoxicillin plus clavulanic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of uncomplicated acute diverticulitis confirmed by a computed tomography (CT) scan within 24-48 hours Exclusion Criteria (prerandomization): immunocompromised patients pregnant women clinical suspicion or CT confirmation of complicated acute diverticulitis Karnofsky performance score less than 50% allergy to penicillin Exclusion Criteria (postrandomization): withdrawal of the trial CT confirmation of complicated acute diverticulitis CT not conforming to acute diverticulitis CT performed 72 hours after the admission adverse reaction to the antibiotic bacteriemia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short intravenous amoxicillin plus clavulanic acid<br>Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days | Drug: amoxicillin plus clavulanic acid<br>* intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days<br>Drug: amoxicillin plus clavulanic acid<br>* intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days<br>|
| Active Comparator: Long intravenous amoxicillin plus clavulanic acid<br>Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days | Drug: amoxicillin plus clavulanic acid<br>* intravenous amoxicillin plus clavulanic acid 1 gr every 8 hours 48 hours followed by oral amoxicillin plus clavulanic acid 1 gr every 8 hours for 10 days<br>Drug: amoxicillin plus clavulanic acid<br>* intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure of treatment |  | the 4th day (group 1) or the 8th day (group 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| emergency admission or hospital readmission for reasons related to the previous diverticulitis |  | 30 days after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diverticulitis