A1 Refereed original research article in a scientific journal
Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis The APPAC II Randomized Clinical Trial
Authors: Sippola Suvi, Haijanen Jussi, Grönroos Juha, Rautio Tero, Nordström Pia, Rantanen Tuomo, Pinta Tarja, Ilves Imre, Mattila Anne, Rintala Jukka, Löyttyniemi Eliisa, Hurme Saija, Tammilehto Ville, Marttila Harri, Meriläinen Sanna, Laukkarinen Johanna, Sävelä Eeva-Liisa, Savolainen Heini, Sippola Tomi, Aarnio Markku, Paajanen Hannu, Salminen Paulina
Publisher: AMER MEDICAL ASSOC
Publication year: 2021
Journal: JAMA: Journal of the American Medical Association
Journal name in source: JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
Journal acronym: JAMA-J AM MED ASSOC
Volume: 325
Issue: 4
First page : 353
Last page: 362
Number of pages: 10
ISSN: 0098-7484
eISSN: 1538-3598
DOI: https://doi.org/10.1001/jama.2020.23525
Self-archived copy’s web address: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7802006/
IMPORTANCE Antibiotics are an effective and safe alternative to appendectomy for managing uncomplicated acute appendicitis, but the optimal antibiotic regimen is not known.
OBJECTIVE To compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography-confirmed uncomplicated acute appendicitis.
DESIGN, SETTING, AND PARTICIPANTS The Appendicitis Acuta (APPAC) II multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. A total of 599 patients aged 18 to 60 years with computed tomography-confirmed uncomplicated acute appendicitis were enrolled in the trial. The last date of follow-up was November 29, 2019.
INTERVENTIONS Patients randomized to receive oral monotherapy (n = 295) received oral moxifloxacin (400 mg/d) for 7 days. Patients randomized to receive intravenous antibiotics followed by oral antibiotics (n = 288) received intravenous ertapenem (1 g/d) for 2 days followed by oral levofloxacin (500 mg/d) and metronidazole (500 mg 3 times/d) for 5 days.
MAIN OUTCOMES AND MEASURES The primary end point was treatment success (>= 65%) for both groups, defined as discharge from hospital without surgery and no recurrent appendicitis during 1-year follow-up, and to determine whether oral antibiotics alone were noninferior to intravenous and oral antibiotics, with a margin of 6% for difference.
RESULTS Among 599 patients who were randomized (mean [SD] age, 36 [12] years; 263 [44%] women), 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at 1 year was 70.2% (1-sided 95% CI, 65.8% to infinity) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to infinity) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to infinity]; P = .26 for noninferiority), with the confidence limit exceeding the noninferiority margin.
CONCLUSION AND RELEVANCE Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin compared with 2 days of intravenous ertapenem followed by 5 days of levofloxacin and metronidazole resulted in treatment success rates greater than 65% in both groups, but failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics.
