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A multicenter, randomized, double blind placebo-controlled trial of amoxicillin/clavulanate for the prophylaxis of fever and infection in neutropenic children with cancer.

Author(s): Castagnola E, Boni L, Giacchino M, Cesaro S, De Sio L, Garaventa A, Zanazzo G, Biddau P, Rossi MR, Schettini F, Bruzzi P, Viscoli C, Infectious Diseases Study Group of the Italian Association of Pediatric Hematology and Oncology

Affiliation(s): Infectious Disease Unit, National Institute for Cancer Research, Largo Rosanna Benzi 10, 16132 Genoa, Italy.

Publication date & source: 2003-04, Pediatr Infect Dis J., 22(4):359-65.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

AIM OF THE STUDY: To evaluate the effectiveness of oral amoxicillin/clavulanate (25 mg/kg every 12 h) for prevention of fever and/or infection in neutropenic children with cancer. METHODS: Multicenter, prospective, randomized, double blind placebo-controlled trial. RESULTS: In the intention-to-treat analysis, amoxicillin/clavulanate had a 12% benefit increase in terms of reduction in the incidence of febrile or infectious episodes, compared with placebo [44 of 83 (53%) vs.55 of 84 (65%); 95% confidence interval, -28% to +3%; P = 0.101]. This benefit was also associated with a 30% increase in the probability of failure-free survival at Day 15 (P = 0.138). A logistic regression analysis showed the effect of prophylaxis to be relevant, especially in patients with leukemia or lymphoma and in those not receiving hematopoietic growth factors, with 17 and 15% absolute benefit increases (logistic P = 0.014 and 0.034, respectively). Compliance with oral drugs was good, with very few and nonsevere drug-related adverse events. CONCLUSIONS: In this study amoxicillin/clavulanate was associated with a detectable clinical effect in the reduction of fever and infection in neutropenic children with cancer, especially those with acute leukemia and not receiving growth factors; the study was not powered to demonstrate a statistically significant effect in the overall patient population.

Page last updated: 2006-01-31

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