Sample size {14}
infectious fever, thirty-four
The reviewed clinical trials and meta-analyses have consistently shown that 65% of patients receiving prophylactic the fluoroquinolones levofloxacin and ciprofloxacin will develop infectious fever (2,17,18) which is consistent with success rate of 35%. Considering that the actual rate of resistance to fluoroquinolones is established to be around 50%, we anticipate a success rate of 17% and 30% in the active control and active and experimental control arms, respectively.If a non-inferiority margin of 5% is defined, one hundred and thirty-four patients (67 in each arm) will be needed to demonstrate non-inferiority of fosfomycin versus ciprofloxacin with 80% potency and an alpha level of 0.05.Considering that 15% of the enrolled patients will be ineligible or unable to be evaluated, the maximum number of study participants will be 156: 78 patients in each arm.