Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis (APPACII)
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|ClinicalTrials.gov Identifier: NCT03236961|
Recruitment Status : Recruiting
First Posted : August 2, 2017
Last Update Posted : August 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Appendicitis||Drug: Ertapenem Drug: Moxifloxacin||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||552 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis: a Prospective Randomised Multicenter Study (The APPAC II Study)|
|Actual Study Start Date :||April 3, 2017|
|Estimated Primary Completion Date :||April 1, 2019|
|Estimated Study Completion Date :||April 1, 2029|
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.
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
Active Comparator: Per oral antibiotics
Moxifloxacin 400 mg x 1 foe seven days, duration of treatment one week.
P.o. moxifloxacin 400 mg x1 for 7 days
- Treatment success [ Time Frame: 1 year ]The resolution of acute uncomplicated appendicitis with allocated antibiotic treatment. Treatment success is defined as discharge from the hospital without the need for surgical intervention after the primary hospitalisation and no recurrent appendicitis during one-year follow-up.
- Late recurrence of appendicitis after antibiotic treatment [ Time Frame: 1 year ]Recurring appendicitis after primary treatment considered successful, thus recurrence after one year
- Duration of hospital stay [ Time Frame: 1 month ]Hospital stay
- Post-intervention complications [ Time Frame: 10 years ]Complications according to the Clavien-Dindo classification
- VAS pain score (visual analogue score) [ Time Frame: 10 years ]Pain as described with a scale from 0-10
- Sick leave [ Time Frame: 1 month ]Duration of sick leave
- Treatment costs [ Time Frame: 1 year ]Treatment costs including hospital stay costs, medicinal costs, imaging costs, costs to treat possible complications, operative costs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03236961
|Contact: Paulina Salminen, MD, PhDemail@example.com|
|Contact: Juha Grönroos, MD, PhDfirstname.lastname@example.org|
|Turku University Hospital||Recruiting|
|Contact: Paulina Salminen email@example.com|
|Principal Investigator: Paulina Salminen, MD, PhD|
|Sub-Investigator: Juha Grönroos, MD, PhD|
|Sub-Investigator: Suvi Sippola, MD|
|Principal Investigator:||Paulina Salminen, MD, PhD||Turku University Hospital|