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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age 18-60 years

• CT confirmed uncomplicated acute appendicitis

• Ability to give consent to participate in the study

Locations
Other Locations
Finland
Turku University Hospital
Turku
Time Frame
Start Date: 2017-04-03
Completion Date: 2029-04-01
Participants
Target number of participants: 552
Treatments
Active_comparator: Intravenous & per oral antibiotics
Ertapenem 1 g x 1 for two days i.v. followed by p.o. levofloxacin 500 mg x 1 and metronidazole 500 mg x 3 for 5 days, duration of treatment one week.
Active_comparator: Per oral antibiotics
Moxifloxacin 400 mg x 1 foe seven days, duration of treatment one week.
Related Therapeutic Areas
Sponsors
Collaborators: Oulu University Hospital, Tampere University Hospital, Mikkeli Central Hospital, Jyväskylä Central Hospital, Seinajoki Central Hospital, Satakunta Central Hospital, Lapland Central Hospital, Kuopio University Hospital
Leads: Turku University Hospital

This content was sourced from clinicaltrials.gov

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