Back to resultsTrial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis (DANC-05)
Primary Purpose
Diverticulitis
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
amoxicillin plus clavulanic acid
amoxicillin plus clavulanic acid
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis focused on measuring Diverticulitis
Eligibility 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
Sites / Locations
- Consorci Sanitari de Terrassa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Short intravenous amoxicillin plus clavulanic acid
Long intravenous amoxicillin plus clavulanic acid
Arm Description
Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days
Outcomes
Primary Outcome Measures
failure of treatment
Secondary Outcome Measures
emergency admission or hospital readmission for reasons related to the previous diverticulitis
Full Information
NCT ID
NCT00917592
First Posted
June 8, 2009
Last Updated
September 26, 2023
Sponsor
Consorci Sanitari de Terrassa
Collaborators
Corporacion Parc Tauli
1. Study Identification
Unique Protocol Identification Number
NCT00917592
Brief Title
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
Acronym
DANC-05
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 Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Consorci Sanitari de Terrassa
Collaborators
Corporacion Parc Tauli
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
Keywords
Diverticulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Short intravenous amoxicillin plus clavulanic acid
Arm Type
Experimental
Arm Description
Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days
Arm Title
Long intravenous amoxicillin plus clavulanic acid
Arm Type
Active Comparator
Arm Description
Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days
Intervention Type
Drug
Intervention Name(s)
amoxicillin plus clavulanic acid
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
amoxicillin plus clavulanic acid
Intervention Description
intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days
Primary Outcome Measure Information:
Title
failure of treatment
Time Frame
the 4th day (group 1) or the 8th day (group 2)
Secondary Outcome Measure Information:
Title
emergency admission or hospital readmission for reasons related to the previous diverticulitis
Time Frame
30 days after discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yolanda Ribas, MD, PhD
Organizational Affiliation
Consorci Sanitari de Terrassa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Consorci Sanitari de Terrassa
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08227
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Trial Assessing the Efficacy of a Short Course of Intravenous Antibiotic Followed by Oral Antibiotic in Uncomplicated Acute Diverticulitis
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