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

Phase 4

Completed

• Conditions: Diverticulitis
• Interventions: Drug: amoxicillin plus clavulanic acid

• Registration Number: NCT00917592
• Lead Sponsor: Consorci Sanitari de Terrassa

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2008-05
• Study Completion: 2008-10
• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short intravenous amoxicillin plus clavulanic acid	amoxicillin plus clavulanic acid	Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
Long intravenous amoxicillin plus clavulanic acid	amoxicillin plus clavulanic acid	Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days

Primary Outcome Measures

Name	Time	Method
failure of treatment	the 4th day (group 1) or the 8th day (group 2)

Secondary Outcome Measures

Name	Time	Method
emergency admission or hospital readmission for reasons related to the previous diverticulitis	30 days after discharge

Trial Locations

Locations (1)

Consorci Sanitari de Terrassa; 🇪🇸 Terrassa, Barcelona, Spain