title: Comparative trials of cefaclor AF in uncomplicated cystitis and asymptomatic bacteriuria.
abstract: Two different doses of cefaclor advanced formulation (AF), a new sustained-release formulation of cefaclor, were compared with the regular formulation of cefaclor for efficacy and safety in the treatment of uncomplicated cystitis and asymptomatic bacteriuria. A 7-day course of treatment was used, and the trials were double-dummy and double-blind. In one trial, cefaclor AF 500 mg once daily (at night) was compared with cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were found in 179/189 (94.7%) and 160/191 (83.8%) patients, respectively, given cefaclor AF and in 82/87 (94.3%) and 74/90 (82.2%) patients given cefaclor, 5-9 days after the end of treatment. In the other trial, cefaclor AF 375 mg twice daily was compared with cefaclor 250 mg three times a day. Satisfactory clinical and bacteriological responses were obtained in 164/180 (91.1%) and 156/184 (84.8%) patients, respectively, given cefaclor AF, and in 86/92 (93.5%) and 81/93 (87.1%) patients taking cefaclor, 5-9 days after the end of treatment. Very similar results were found in both studies in those patients who were assessable 3-5 weeks later. Only 4.3% and 2.4% of patients treated with cefaclor AF (375 mg and 500 mg, respectively) and 2.2% of cefaclor patients discontinued therapy due to adverse events. The three most commonly reported events were vaginal moniliasis or vaginitis (8.6%), headache (5.0%) and nausea (4.8%). No significant differences were found between clinical efficacy and safety parameters in the different study groups, and it was concluded that cefaclor AF in a twice-daily or once-daily dosage is as effective and as safe as the currently recommened three-times-a-day dosage of cefaclor.
authors.affiliation: Department of Medical Microbiology, Royal Free Hospital School of Medicine, London, UK.
authors.forename: J M
authors.initials: JM
authors.lastname: Hamilton-Miller
authors.forename: A
authors.initials: A
authors.lastname: Iravani
authors.forename: W
authors.initials: W
authors.lastname: Brumfitt
authors.forename: K S
authors.initials: KS
authors.lastname: Byers
authors.forename: W H
authors.initials: WH
authors.lastname: Dere
mesh_terms: D000293:Adolescent; D001437:Bacteriuria / Q000188:drug therapy*; D002433:Cefaclor / Q000008:administration & dosage / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D003556:Cystitis / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests
chemical_list: D003692:Delayed-Action Preparations; D002433:Cefaclor