Oral antibiotics alone not noninferior to IV, oral antibiotics for acute appendicitis
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Among adults with uncomplicated acute appendicitis, treatment with 7 days of oral moxifloxacin is not noninferior to a combination of IV and oral antibiotics, researchers reported.
The results are from the Appendicitis Acuta (APPAC) II trial, a randomized clinical trial conducted in Finland. The initial APPAC trial compared appendectomy with antibiotics for CT-confirmed uncomplicated acute appendicitis and showed that antibiotics “were a safe and effective treatment option both at 1 and 5 years,” said Paulina Salminen, MD, PhD, professor of surgery at the University of Turku and Turku University Hospital.
For APPAC II, “we wanted to assess optimizing the antibiotic treatment,” Salminen told Healio.
According to Salminen, in the original APPAC trial, the patients received antibiotics for 10 days with three IV doses. However, in APPAC II, Salminen and colleagues compared a combination of intravenous antibiotics, followed by oral antibiotics to just oral antibiotics, with a treatment duration of 7 days.
“Given that nonoperative treatment for uncomplicated acute appendicitis was well established and now also confirmed from several clinical trials, the primary objective of this APPAC II trial was to demonstrate the ability of oral antibiotics alone to manage acute appendicitis and to assess the noninferiority between these antibiotic treatments,” Salminen said.
The researchers included 583 adults with uncomplicated acute appendicitis from nine Finnish hospitals who were treated with either 7 days of oral moxifloxacin or 2 days intravenous ertapenem, followed by 5 days of levofloxacin and metronidazole.
According to the study, among 599 patients who were randomly assigned, 581 (99.7%) were available for the 1-year follow-up. The treatment success rate at the 1-year mark was 70.2% for patients treated with oral antibiotics alone and 73.8% for patients treated with IV followed by oral antibiotics, a result that failed to demonstrate noninferiority for treatment success for the oral-only treatment, the researchers noted.
Salminen called the success rates “very consistent” with the initial APPAC trial findings and also with other recent trials, when using the same criteria for defining uncomplicated and complicated acute appendicitis.
“The accurate preintervention diagnosis of appendicitis severity is of great importance as uncomplicated and complicated acute appendicitis are clinically two different diseases. The patients in this APPAC II trial had a CT-confirmed uncomplicated acute appendicitis (no appendicolith, no perforation, no abscess, no suspicion of tumor),” Salminen said. “Antibiotic treatment, and now even just oral antibiotics, is a safe and efficient treatment alternative for CT-confirmed uncomplicated acute appendicitis.”
In a related editorial, Peter C. Minneci, MD, MHSc, and Katherine J. Deans, MD, MHSc, both of Nationwide Children’s Hospital in Columbus, Ohio, said, ‘This is a critical first study related to better defining treatment strategies because it opens up a larger potential area of application in the outpatient setting.’”
Salminen said a shorter hospital stay or even outpatient treatment for antibiotic therapy could further enhance cost savings, patient satisfaction and quality of life, adding that “because of the high prevalence of acute appendicitis, especially during the COVID-19 pandemic, the feasibility, efficacy, and safety of treatment options enabling avoidance of hospitalization and the possibility of redirecting health care resources are of vital importance.”
References:
Minneci PC, et al. JAMA. 2021;doi:10.1001/jama.2020.23607.
Sippola S, et al. JAMA. 2021;doi:10.1001/jama.2020.23525.
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