BAYER/SCHERING-PLOUGHFluoroquinolone antibiotic approved for cIAI
A synthetic broad-spectrum antibacterial agent, moxifloxacin exerts its bactericidal action through inhibition of the topoisomerase II and topoisomerase IV required for bacterial DNA replication, transcription, repair, and recombination. Moxifloxacin was approved on November 22, 2005, for the treatment of complicated intra-abdominal infections (cIAI) including polymicrobial infections such as abscesses caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosis, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus spp.
Efficacy. The efficacy of moxifloxacin in the treatment of cIAI was evaluated in 2 randomized, active-controlled trials. The North American trial was a double-blind study comparing the efficacy of sequential IV/PO moxifloxacin 400 mg qd for 5 to 14 days with that of IV/PO piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatments of patients with cIAI (N=681), including peritonitis, abscesses, appendicitis with perforation, and bowel perforation. Clinical success rates for the moxifloxacin and comparator groups were 79.8% and 78.1%, respectively (95% CI, –7.4 to 9.3). The international trial was an open-label study comparing the efficacy of moxifloxacin 400 mg qd for 5 to 14 with that of IV ceftriaxone plus IV metronidazole followed by PO amoxicillin/clavulanic acid in the treatment of patients with cIAI (N=595). Clinical success rates for the moxifloxacin and comparator groups were 80.9% and 82.3%, respectively (95% CI, –8.9 to 4.2).
Dosing. The recommended dose of moxifloxacin is 400 mg (orally or as an IV infusion) once every 24 hours. For cIAIs, therapy should usually be initiated with the IV formulation, and the duration of therapy should last from 5 to 14 days.