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

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ClinicalTrials.gov Identifier: NCT00917592
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : June 10, 2009
Sponsor:
Collaborator:
Corporacion Parc Tauli
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Diverticulitis Drug: amoxicillin plus clavulanic acid Phase 4

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  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2005
Actual Primary Completion Date : May 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. failure of treatment [ Time Frame: the 4th day (group 1) or the 8th day (group 2) ]

Secondary Outcome Measures :
  1. emergency admission or hospital readmission for reasons related to the previous diverticulitis [ Time Frame: 30 days after discharge ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Yolanda Ribas Blasco, Department of Surgery
ClinicalTrials.gov Identifier: NCT00917592     History of Changes
Other Study ID Numbers: DANC-05
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: June 10, 2009
Last Verified: June 2009

Keywords provided by Consorci Sanitari de Terrassa:
Diverticulitis

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Amoxicillin
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors