Early clinical assessment of the antimicrobial activity of finafloxacin compared to ciprofloxacin in sub-sets of microbiologically characterized isolates [PublishAheadOfPrint]

Introduction

Two phase II studies were performed in patients with uncomplicated (uUTI) and complicated urinary tract infections or acute pyelonephritis (cUTI/PN) to compare finafloxacin (300 mg b.i.d, p.o. for uUTI 800 mg q.d., i.v. for cUTI/PN) and ciprofloxacin (250 mg b.i.d, p.o. for uUTI and 400 mg b.i.d., i.v. for cUTI/PN). The early response to the study medications was evaluated in the microbiological-intent-to treat population (mITT) at day 3.

Results

21% of the isolates were ciprofloxacin-resistant, 13.7 % were primed pathogens carrying mutation(s) potentially fostering fluoroquinolone-resistance development, and 7.1 % produced ESBLs. Finafloxacin demonstrated very good early clinical activity with microbiological eradication rates of 88.6% (n=132) compared to 78.7% (n=61) for ciprofloxacin, and 69.6% (n=23) compared to 35.7% (n=14) for ciprofloxacin in patients with ciprofloxacin-resistant, and 94.1% (n=17) compared to 80.0% (n=10) for ciprofloxacin in patients infected with uropathogens primed for fluoroquinolone-resistance uropathogens, and 91.7% (n=11) for finafloxacin compared to 0% for ciprofloxacin in patients infected with ESBL-producers.

Conclusions

Finafloxacin demonstrated an early and rapid activity against uropathogens including fluoroquinolone- and/or multi-resistant or ESBL-producers while ciprofloxacin was less active against this subset of resistant pathogens.

Methods

Susceptibilities of pathogens were quantitated by broth microdilution. Isolates were subgrouped according to their susceptibility-patterns, in particular first-step-quinolone-resistance, quinolone-resistance, and ESBL-production. Eradication was defined as elimination or reduction of study entry pathogens to <10³ CFU/ml in urine culture.

http://ift.tt/2rf7RRg