Title

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

    Phase 4
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Study Participants

    50
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.
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 Started
Dec 31
2005
Primary Completion
May 31
2008
Study Completion
Oct 31
2008
Last Update
Aug 23
2021

Drug amoxicillin plus clavulanic acid

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

Drug amoxicillin plus clavulanic acid

intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days

Short intravenous amoxicillin plus clavulanic acid Experimental

Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days

Long intravenous amoxicillin plus clavulanic acid Active Comparator

Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days

Criteria

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
No Results Posted