Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis

Summary

Appendicectomy has been the treatment of acute appendicitis for over a hundred years. Appendicectomy, however, includes operative and postoperative risks despite being a routine procedure. Several studies have proved promising results of the safety and efficiency of antibiotics in the treatment of acute uncomplicated appendicitis. The APPAC study by the investigators, published in 2015 in the Journal of American Medical Association, also proved promising results with 73% of patients with uncomplicated appendicitis treated successfully with antibiotics. None of the patients initially treated with antibiotics that later had appendectomy had major complications. The results of the APPAC trial suggest that CT proven uncomplicated acute appendicitis is not a surgical emergency and antibiotic therapy is a safe first-line treatment option. Reducing unnecessary appendectomies has also been shown to lead to significant economic savings.

The aim of this randomized prospective study is to optimize antibiotic therapy for uncomplicated acute appendicitis by comparing different antibiotic regimens; intravenous antibiotic (ertapenem) followed by per oral antibiotic (levofloxacin and metronidazole) with only per oral antibiotics (moxifloxacin). Before randomization, the diagnosis of acute uncomplicated appendicitis is confirmed with a CT scan.

The hypothesis is that broad-spectrum intravenous antibiotics requiring additional hospital resources are not necessary for the treatment of uncomplicated acute appendicitis and that per oral mono therapy is non-inferior to the combination of intravenous and per oral antibiotic therapy.

Conditions

• Acute Appendicitis

Interventions

DRUG

Ertapenem

I.v. ertapenem 1 g for 2 days followed by p.o. levofloxacin 500 mg x1 and metronidazole 500 mg x 3 for 5 days

DRUG

Moxifloxacin

P.o. moxifloxacin 400 mg x1 for 7 days

Sponsors & Collaborators

• Oulu University Hospital

  collaborator OTHER

• Tampere University Hospital

  collaborator OTHER

• Kuopio University Hospital

  collaborator OTHER

• Mikkeli Central Hospital

  collaborator OTHER

• Lapland Central Hospital

  collaborator UNKNOWN

• Jyväskylä Central Hospital

  collaborator OTHER

• Satakunta Central Hospital

  collaborator OTHER

• Seinajoki Central Hospital

  collaborator OTHER

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Paulina Salminen, MD, PhD · Turku University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-04-03

Primary Completion

2018-11-27

Completion

2029-04-01

Countries

• Finland

Study Locations