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

This study has been completed.
Sponsor:
Collaborator:
Corporacion Parc Tauli
Information provided by:
Consorci Sanitari de Terrassa
ClinicalTrials.gov Identifier:
NCT00917592
First received: June 8, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diverticulitis
Drug: amoxicillin plus clavulanic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Consorci Sanitari de Terrassa:

Primary Outcome Measures:
  • failure of treatment [ Time Frame: the 4th day (group 1) or the 8th day (group 2) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • emergency admission or hospital readmission for reasons related to the previous diverticulitis [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: December 2005
Study Completion Date: October 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917592

Locations
Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Sponsors and Collaborators
Consorci Sanitari de Terrassa
Corporacion Parc Tauli
Investigators
Principal Investigator: Yolanda Ribas, MD, PhD Consorci Sanitari de Terrassa
  More Information

No publications provided

Responsible Party: Yolanda Ribas Blasco, Department of Surgery
ClinicalTrials.gov Identifier: NCT00917592     History of Changes
Other Study ID Numbers: DANC-05
Study First Received: June 8, 2009
Last Updated: June 8, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Consorci Sanitari de Terrassa:
Diverticulitis

Additional relevant MeSH terms:
Diverticulitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Amoxicillin
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014