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

Consorci Sanitari de Terrassa

Status and phase: Completed; Phase 4

Conditions: Diverticulitis

Treatments: Drug: amoxicillin plus clavulanic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT00917592

DANC-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Short intravenous amoxicillin plus clavulanic acid

Experimental group

Description:

Intravenous antibiotic 48 hours followed by oral antibiotic for 10 days

Treatment:

Drug: amoxicillin plus clavulanic acid

Drug: amoxicillin plus clavulanic acid

Long intravenous amoxicillin plus clavulanic acid

Active Comparator group

Description:

Intravenous antibiotic for 7 days followed by oral antibiotic for 5 days

Treatment:

Drug: amoxicillin plus clavulanic acid

Drug: amoxicillin plus clavulanic acid