Results of a pilot trial comparing prolonged intravenous antibiotics with sequential intravenous/oral antibiotics for children with perforated appendicitis

Hypothesis: For children with perforated appendicitis, the use of a prolonged course of intravenous (IV) antibiotics is equivalent to a short course of IV antibiotics followed by sequential conversion to oral (PO) antibiotics. Design: Prospective, randomized, clinical trial. Setting: Multicenter study in tertiary children's hospitals. Patients: Children (aged 5-18 years) with perforated appendicitis found at laparotomy. Intervention: Children were randomized after appendectomy either to a 10-day course of a combination of IV ampicillin, gentamicin sulfate, and clindamycin (n = 10); or to a short course of a combination of IV ampicillin, gentamicin, and clindamycin, followed by conversion to a combination of PO amoxicillin and clavulanate potassium plus metronidazole (n = 16). Main Outcome Measures: The primary outcome measure was clinical success, which was rated as complete, partial, or failure. Secondary outcome measures included return of oral intake, duration of fever, return of normal white blood cell count, and patient charges. Treatment equivalence was determined using confidence interval analysis. Results: We found treatment equivalence between the IV and IV/PO groups, with 6 (60%) complete and 4 (40%) partial successes for the 10 patients in the IV group and 15 (94%) complete and 1 (6%) partial successes for the 16 patients in the IV/PO group (P less than or equal to .05). There was no difference in return of oral intake, duration of fever, or return of normal white blood cell count between the groups. Conversion to oral therapy results in savings of approximately $1500 per case. Conclusion: There is treatment equivalence between prolonged IV therapy and IV therapy followed by conversion to oral antibiotic therapy in children with perforated appendicitis.