Clinical question: Are oral antibiotics effective and non-inferior to a combination of intravenous and oral antibiotics?
Background: Evidence over the past 10 years suggests that antibiotics are a safe alternative to appendectomy in treating acute uncomplicated appendicitis. In prior studies, researchers have evaluated the use of intravenous antibiotics with transition to oral antibiotics, but the effectiveness of a single, oral antibiotic for the treatment of acute uncomplicated appendicitis has yet to be evaluated.
Study design: Randomized, open label, noninferiority, multi-center trial between April 2017 and November 2018
Setting: Nine Finnish Hospitals, (four university hospitals and five central hospitals)
Synopsis: A total of 599 patients with computed tomography-confirmed, acute, uncomplicated appendicitis were included. Patients ranged in age from 18 to 60 years (mean age of 36 ±12 years), and 43.9% were women. Patients were randomized to receive either oral moxifloxacin (400 mg once daily) for seven days, or intravenous ertapenem (1 g once daily) for two days followed by oral levofloxacin (500 mg daily) plus metronidazole (500 mg three times per day) for five days. Both groups achieved the primary endpoint defined as >65% of patients discharged without surgery and no recurrence for over one year. The treatment success rate at one year was 70.2% (one-sided 95% confidence interval, 65.8% to infinity) for the oral moxifloxacin group and 73.8% (one-sided 95% confidence interval, 69.5% to infinity) for the intravenous ertapenem followed by oral levofloxacin plus metronidazole group. The difference was -3.6% (one-sided 95% confidence interval, -9.7% to infinity), which exceeded the non-inferiority margin that was predefined as -6% (P=0.26). The median length of stay was similar in both groups at approximately one day.
Bottom Line: Patients with acute uncomplicated appendicitis were successfully treated with oral moxifloxacin alone. Even though oral moxifloxacin did not meet statistical criteria for non-inferiority, the results support that oral moxifloxacin may be a reasonable option for patients with acute uncomplicated appendicitis who hope to avoid surgery.
Citation: Sippola S, et al. Effect of oral moxifloxacin vs intravenous ertapenem plus oral levofloxacin for treatment of uncomplicated acute appendicitis: The APPAC II randomized clinical trial. JAMA. 2021;325(4):353-362. doi:10.1001/jama.2020.23525.
Dr. Andleeb is an assistant professor of internal medicine at Wake Forest School of Medicine, Winston-Salem, N.C