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

Sponsor

Consorci Sanitari de Terrassa (Other)

Overall Status

Completed

CT.gov ID

NCT00917592

Collaborator

Corporacion Parc Tauli (Other)

Enrollment

Location

Arms

Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diverticulitis	Drug: amoxicillin plus clavulanic acid 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 Design

Study Type:

Interventional

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 :

Dec 1, 2005

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Oct 1, 2008

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

failure of treatment [the 4th day (group 1) or the 8th day (group 2)]

Secondary Outcome Measures

emergency admission or hospital readmission for reasons related to the previous diverticulitis [30 days after discharge]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yolanda Ribas, Principal Investigator, Consorci Sanitari de Terrassa

ClinicalTrials.gov Identifier:

NCT00917592

Other Study ID Numbers:

DANC-05

First Posted:

Jun 10, 2009

Last Update Posted:

Aug 23, 2021

Last Verified:

Aug 1, 2021

Keywords provided by Yolanda Ribas, Principal Investigator, Consorci Sanitari de Terrassa

Diverticulitis

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 23, 2021