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ACTIVE NOT RECRUITING
NCT03236961
NA

Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis

Sponsor: Turku University Hospital

View on ClinicalTrials.gov

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.

Official title: Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis: a Prospective Randomised Multicenter Study (The APPAC II Study)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

552

Start Date

2017-04-03

Completion Date

2029-04-01

Last Updated

2020-11-12

Healthy Volunteers

No

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

Locations (1)

Turku University Hospital

Turku, Finland