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

Diverticulitis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917592
• Other study ID #: DANC-05
• Status: Completed
• Phase: Phase 4
• Start date: December 2005
• Est. completion date: October 2008

Study information

• Verified date: September 2023
• Source: Consorci Sanitari de Terrassa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diverticulitis

Intervention

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
• amoxicillin plus clavulanic acid
intravenous amoxicillin plus clavulanic acid for 7 days followed by oral antibiotic for 5 days

Locations

Country	Name	City	State
Spain	Consorci Sanitari de Terrassa	Terrassa	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Consorci Sanitari de Terrassa	Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	failure of treatment		the 4th day (group 1) or the 8th day (group 2)
Secondary	emergency admission or hospital readmission for reasons related to the previous diverticulitis		30 days after discharge