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 prolong ed course of intravenous (IV) antibiotics is equivalent to a short course o f 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-da y course of a combination of IV ampicillin, gentamicin sulfate, and clindam ycin (n = 10); or to a short course of a combination of IV ampicillin, gent amicin, and clindamycin, followed by conversion to a combination of PO amox icillin and clavulanate potassium plus metronidazole (n = 16). Main Outcome Measures: The primary outcome measure was clinical success, wh ich was rated as complete, partial, or failure. Secondary outcome measures included return of oral intake, duration of fever, return of normal white b lood 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, wi th 6 (60%) complete and 4 (40%) partial successes for the 10 patients in th e IV group and 15 (94%) complete and 1 (6%) partial successes for the 16 pa tients in the IV/PO group (P less than or equal to .05). There was no diffe rence in return of oral intake, duration of fever, or return of normal whit e blood cell count between the groups. Conversion to oral therapy results i n 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 w ith perforated appendicitis.