Does the high-dose, short-course levofloxacin have a role to play in the treatment of cUTI?
We participated in a non-inferiority trial comparing 750 mg levofloxacin once daily for 5 days with ciprofloxacin 400 mg IV or 500 mg PO twice daily for 10 days in the management of cUTI or AP. Among the cUTI patients the most commonly isolated pathogen was E. coli. Results confirmed that a 5-day schedule of 750 mg levofloxacin was at least as clinically and microbiologically effective as ciprofloxacin twice daily for 10 days. The E. coli eradication rate in the modified intent-to-treat (ITT) population was 80.1% in the levofloxacin group versus 73.1% in the ciprofloxacin group. These results were also true for patients with pyelonephritis. In this study, the safety and efficacy of the high-dose regimen for cUTI and AP was demonstrated leading to approval of this indication for the 750 mg dose as well.