Prulifloxacin: clinical studies of a broad-spectrum quinolone agent.

Prulifloxacin, the lipophilic prodrug of ulifloxacin, is a new oral fluoroquinolone with a broad spectrum of in vitro activity against various Gram-positive and Gram-negative microorganisms. Currently, it is the most potent in vitro fluoroquinolone against Escherichia coli and Pseudomonas aeruginosa, and also has the lowest potential of inducing the emergence of resistant strains for these bacteria. It exhibits good penetration in target tissues and fluids, and possesses a long half-life, thus allowing for once-daily administration. Prulifloxacin has been successfully tested in Phase III randomized, controlled trials including patients with acute exacerbations of chronic bronchitis, uncomplicated and complicated urinary tract infections, and chronic bacterial prostatitis. Results are awaited from recently completed and ongoing Phase III randomized, placebo-controlled studies testing prulifloxacin for the treatment of traveler's diarrhea. Prulifloxacin has an acceptable toxicity profile, comparable to that of other fluoroquinolones, with gastric disturbances, diarrhea, nausea and skin rash of mild-to-moderate severity being the most frequent adverse events. Additional research is needed to further elucidate the promising role of prulifloxacin in the treatment of infections sustained by multidrug-resistant pathogens and to consolidate the wide spectrum of activity from a clinical standpoint.