title: Treatment of complicated intra-abdominal infections: comparison of the tolerability and safety of intravenous/oral trovafloxacin versus intravenous imipenem/cilastatin switching to oral amoxycillin/clavulanic acid.
abstract: Three- to four-times-daily intravenous (i.v.) imipenem/cilastatin switching to oral amoxycillin/clavulanic acid is often used to manage complicated intra-abdominal infections. Trovafloxacin, a clinically and bacteriologically proven new-generation fluoroquinolone antibiotic, given as single-agent, once-daily i.v./oral therapy, can provide equivalent clinical and bacteriological efficacy. Tolerability and safety of up to 14 days treatment with 300 mg i.v. alatrofloxacin (the prodrug of trovafloxacin) switching to 200 mg oral trovafloxacin were compared with those of 1 g i.v. imipenem/cilastatin switching to 625 mg oral amoxycillin/clavulanic acid. Comparable incidences of adverse events, mainly mild or moderate in intensity, were experienced in each treatment group. For both therapies, gastrointestinal events were most common, but diarrhoea was reported by proportionately more comparator group patients. In conclusion, once-daily i.v.-to-oral trovafloxacin has a comparable safety profile to i.v. imipenem/cilastatin followed by oral amoxycillin/clavulanic acid. Cost saving may be achieved with trovafloxacin due to the lack of any need to monitor creatinine levels and the once-daily dosing regimen that allows a switch to the same orally administered drug.
authors.affiliation: Department of Clinical Research, Pfizer Inc, Groton, Connecticut, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Luke
authors.forename: J
authors.initials: J
authors.lastname: Peterson
mesh_terms: D000005:Abdomen; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage; D001424:Bacterial Infections / Q000188:drug therapy*; D015377:Cilastatin / Q000008:administration & dosage; D019818:Clavulanic Acid / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D024841:Fluoroquinolones; D006801:Humans; D015378:Imipenem / Q000008:administration & dosage; D007262:Infusions, Intravenous; D008297:Male; D009287:Naphthyridines / Q000008:administration & dosage; D010532:Peritoneal Diseases / Q000188:drug therapy*
chemical_list: D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D024841:Fluoroquinolones; D009287:Naphthyridines; D015377:Cilastatin; D019818:Clavulanic Acid; D015378:Imipenem; D000658:Amoxicillin; C080163:trovafloxacin