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Completed

NCT Number: NCT00917592

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

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.

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

amoxicillin plus clavulanic acid

Drug

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

Primary outcomes

  1. failure of treatment

    Time frame: the 4th day (group 1) or the 8th day (group 2)

Secondary outcomes

  1. emergency admission or hospital readmission for reasons related to the previous diverticulitis

    Time frame: 30 days after discharge

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Collaborators

  • Corporacion Parc Tauli

Registry information

Official study 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

Acronym: DANC-05

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jun 10, 2009
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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