APPIC
Trial question
Is a short 2-day course of postoperative antibiotics noninferior to a standard 5-day course in patients with complex appendicitis?
Study design
Multi-center
Open label
RCT
Population
1005 patients
Inclusion criteria: patients aged ≥ 8 years with complex appendicitis
Key exclusion criteria: no informed consent; interval appendectomy; clinical suspicion of severe sepsis; conservative treatment of acute appendicitis; immunocompromised state; pregnancy
Interventions
N=502 short 2-day course (intravenous cefuroxime/metronidazole 1,500/500 mg TID or ceftriaxone/metronidazole once daily 2,000 mg/TID 500 mg for 48 hours according to local antibiotic policy)
N=503 standard 5-day course (intravenous cefuroxime/metronidazole 1,500/500 mg TID or ceftriaxone/metronidazole once daily 2,000 mg/TID 500 mg for 5 days according to local antibiotic policy)
Primary outcome
Rate of infectious complications and death within 90 days
10
8
10.0 %
7.5 %
5.0 %
2.5 %
0.0 %
Short 2-day course
Standard 5-day course
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in the rate of infectious complications and death within 90 days (10% vs. 8%; AD 2%, 95% CI -1.6 to 5.6)
Secondary outcomes
Borderline significant increase in hospital readmission (12% vs. 6%; OR 2.135, 95% CI 1.34 to 3.4)
Borderline significant decrease in adverse effects of antibiotics (9% vs. 22%; OR 0.344, 95% CI 0.24 to 0.5)
Conclusion
In patients aged ≥ 8 years with complex appendicitis, short 2-day course was noninferior to standard 5-day course with respect to the rate of infectious complications and death within 90 days.
Reference
Elisabeth M L de Wijkerslooth, Evert-Jan G Boerma, Charles C van Rossem et al. 2 days versus 5 days of postoperative antibiotics for complex appendicitis: a pragmatic, open-label, multicentre, non-inferiority randomised trial. Lancet. 2023 Jan 17;S0140-6736(22)02588-0.
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