Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis (DANC-05)

September 26, 2023 updated by: Yolanda Ribas, Consorci Sanitari de Terrassa

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Terrassa, Barcelona, Spain, 08227
        • Consorci Sanitari de Terrassa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Short intravenous amoxicillin plus clavulanic acid
Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
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
Active Comparator: Long intravenous amoxicillin plus clavulanic acid
Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Consorci Sanitari de Terrassa

Collaborators

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Yolanda Ribas, MD, PhD, Consorci Sanitari de Terrassa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 8, 2009

First Posted (Estimated)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DANC-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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