In adults with uncomplicated acute appendicitis, treatment with oral moxifloxacin alone vs intravenous ertapenem followed by oral levofloxacin and metronidazole resulted in success rates greater than 65% in both groups, according to results published in JAMA. Oral antibiotic monotherapy failed to demonstrate noninferiority compared with intravenous followed by oral antibiotics.
In this randomized, open-label, noninferiority multicenter trial (ClinicalTrials.gov Identifier: NCT03236961) conducted at 9 Finnish hospitals, researchers tested the hypothesis of whether oral antibiotics were effective alone and noninferior to intravenous antibiotics followed by oral antibiotics for treating uncomplicated acute appendicitis as first-line therapy. Adult patients were randomly assigned in a 1:1 ratio to receive either oral moxifloxacin (400 mg once daily) for 7 days or intravenous ertapenem (1 g once daily) for 2 days followed by oral levofloxacin (500 mg a day) and metronidazole (500 mg 3 times daily) for 5 days.
The primary end point was treatment success at 1 year, defined as discharge from the hospital without surgical intervention and no recurrent appendicitis during the 1-year follow-up. The rate of success for treatment was set to 65% or higher. Noninferiority margin was set to less than 6%.
The primary analyses included 583 patients (women, n=263) with a mean age of 36 years. Baseline characteristics were similar between the groups. Of the 583 patients, 581 (99.7%) completed the 1-year follow-up.
Among the 295 patients who received oral moxifloxacin, the treatment success rate at 1 year was 70.2%. Of the 288 patients who received intravenous ertapenem followed by oral levofloxacin and metronidazole, the treatment success rate was 73.8%. The analysis yielded a difference of -3.6% (P =.26 for noninferiority).
Appendectomy during initial hospitalization occurred in 9.2% of patients (27/295) in the oral moxifloxacin group and 7.6% of patients (22/288) in the intravenous followed by oral antibiotics group. During the 1-year follow-up, an additional 20.7% of patients (61/295) underwent an appendectomy for suspected recurrent appendicitis (87 days; interquartile range [IQR], 39-154) in the oral moxifloxacin group vs 18.5% of patients (53/288) in the intravenous followed by oral antibiotics group (120 days; IQR, 76-211).
There were no statistically significant difference between the treatment groups in the length of hospital stay and no deaths occurred during the 1-year follow-up.
Researchers noted that since moxifloxacin is a broad-spectrum antibiotic, there are risks for developing antibiotic resistance. Future studies will need to refine the diagnosis of appendicitis severity using uniform and standardized criteria and define optimal treatment strategies.
Sippola S, Haijanan J, Grönroos J, 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. Published online January 11, 2021. doi:10.1001/jama.2020.23525