Oral antibiotics alone noninferior to IV followed by oral antibiotics in appendicitis patients: JAMA
Finland: Adults with uncomplicated acute appendicitis treated with oral antibiotics versus IV followed by oral antibiotics had almost equal treatment success, finds a recent study in the journal JAMA.
According to the study, 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. However, it failed to demonstrate noninferiority for treatment success of oral antibiotics compared with intravenous followed by oral antibiotics.
In patients with uncomplicated acute appendicitis, antibiotics are an safe and effective alternative to appendectomy for the management of the condition, but the optimal antibiotic regimen is not known. Considering the same, Suvi Sippola, Turku University Hospital, Turku, Finland, and colleagues aimed to compare oral antibiotics with combined intravenous followed by oral antibiotics in the management of computed tomography–confirmed uncomplicated acute appendicitis.
For the purpose, the researchers designed the Appendicitis Acuta (APPAC) II -- a multicenter, open-label, noninferiority randomized clinical trial was conducted from April 2017 until November 2018 in 9 Finnish hospitals. The trial enrolled a total of 599 patients (aged 18 to 60 years) with computed tomography–confirmed uncomplicated acute appendicitis. The last date of follow-up was November 29, 2019.
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. 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 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.
Key findings of the study include:
- The treatment success rate at 1 year was 70.2% for patients treated with oral antibiotics and 73.8% for patients treated with intravenous followed by oral antibiotics.
- The difference was −3.6% with the confidence limit exceeding the noninferiority margin.
"Patients with acute, uncomplicated appendicitis treated with oral antibiotics alone met the prespecified threshold for treatment success, but failed to demonstrate noninferiority relative to systemic antibiotics followed by oral antibiotics," concluded the authors.
"Effect of Oral Moxifloxacin vs Intravenous Ertapenem Plus Oral Levofloxacin for Treatment of Uncomplicated Acute Appendicitis: The APPAC II Randomized Clinical Trial," is published in the journal JAMA.
DOI: https://jamanetwork.com/journals/jama/fullarticle/2775227
