Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis: The APPAC II Randomized Clinical Trial.

Autor:	Sippola S; Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.; Department of Surgery, University of Turku, Turku, Finland., Haijanen J; Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.; Department of Surgery, University of Turku, Turku, Finland.; Department of Surgery, Satakunta Central Hospital, Pori, Finland., Grönroos J; Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.; Department of Surgery, University of Turku, Turku, Finland., Rautio T; Department of Surgery, Oulu University Hospital, Oulu, Finland.; Medical Research Center Oulu, University of Oulu, Finland., Nordström P; Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.; Faculty of Medicine and Health Technology, University of Tampere, Tampere, Finland., Rantanen T; Department of Surgery, Kuopio University Hospital, Kuopio, Finland.; Department of Surgery, Institute of Clinical Medicine, University of Eastern Finland., Pinta T; Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland., Ilves I; Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland., Mattila A; Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland., Rintala J; Department of Surgery, Oulu University Hospital, Oulu, Finland.; Department of Surgery, Rovaniemi Central Hospital, Rovaniemi, Finland., Löyttyniemi E; Department of Biostatistics, University of Turku, Turku, Finland., Hurme S; Department of Biostatistics, University of Turku, Turku, Finland., Tammilehto V; Department of Radiology, Turku University Hospital, Turku, Finland., Marttila H; Department of Hospital Hygiene & Infection Control, Turku University Hospital, Turku, Finland., Meriläinen S; Department of Surgery, Oulu University Hospital, Oulu, Finland.; Medical Research Center Oulu, University of Oulu, Finland., Laukkarinen J; Department of Gastroenterology and Alimentary Tract Surgery, Tampere University Hospital, Tampere, Finland.; Faculty of Medicine and Health Technology, University of Tampere, Tampere, Finland., Sävelä EL; Department of Surgery, Satakunta Central Hospital, Pori, Finland., Savolainen H; Department of Surgery, Kuopio University Hospital, Kuopio, Finland., Sippola T; Department of Surgery, Seinäjoki Central Hospital, Seinäjoki, Finland., Aarnio M; Department of Surgery, Jyväskylä Central Hospital, Jyväskylä, Finland., Paajanen H; Department of Surgery, Mikkeli Central Hospital, Mikkeli, Finland., Salminen P; Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.; Department of Surgery, University of Turku, Turku, Finland.
Jazyk:	angličtina
Zdroj:	JAMA [JAMA] 2021 Jan 26; Vol. 325 (4), pp. 353-362.
DOI:	10.1001/jama.2020.23525
Abstrakt:	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 ∞) for patients treated with oral antibiotics and 73.8% (1-sided 95% CI, 69.5% to ∞) for patients treated with intravenous followed by oral antibiotics. The difference was -3.6% ([1-sided 95% CI, -9.7% to ∞]; 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. Trial Registration: ClinicalTrials.gov Identifier: NCT03236961; EudraCT Identifier: 2015-003633-10.
Databáze:	MEDLINE
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