Randomized, double-blind, multicenter comparison of oral cefditoren 200 or 400 mg BID with either cefuroxime 250 mg BID or cefadroxil 500 mg BID for the treatment of uncomplicated skin and skin-structure infections

• Published in: Clinical therapeutics 2002-07, Vol.24 (7), p.1134-1147
• Main Authors: Bucko, Alicia D., Hunt, Barbara J., Kidd, Sarah L., Hom, Richard
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Amides; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; cefadroxil; Cefadroxil - administration & dosage; Cefadroxil - therapeutic use; Cefditoren; Cefuroxime; Cefuroxime - administration & dosage; Cefuroxime - therapeutic use; Cellulitis; Cephalosporins; Cephalosporins - administration & dosage; Cephalosporins - therapeutic use; Child; Clinical trials; Demographics; Diarrhea; Double-Blind Method; Double-blind studies; Drug Administration Schedule; Drug Therapy, Combination - administration & dosage; Drug Therapy, Combination - therapeutic use; Eradication; Female; Females; Headache; Humans; Infections; Laboratory tests; Male; Males; Medical sciences; Middle Aged; Nausea; Pathogens; Patients; Pharmacology. Drug treatments; Physical examinations; Randomization; Skin; skin and soft tissue infection; Skin Diseases, Infectious - drug therapy; Soft Tissue Infections - drug therapy; Streptococcus infections; Treatment Outcome; Wound infection; β-Lactam antibiotics
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(02)80024-8

Background: Uncomplicated skin and skin-structure infections are commonly observed in medical practice. Because these infections typically are confined to the superficial layers and seldom lead to the destruction of skin structures and resultant systemic dissemination, in general they can be treated with an oral antibiotic with potent microbiologic activity against gram-positive pathogens. Objective: This paper compares the efficacy and tolerability of 3 beta-lactam antibiotics in patients with uncomplicated skin and skin-structure infections. Methods: Two double-blind, multicenter, parallel-group studies were conducted, in which patients aged ≥12 years with uncomplicated skin and skin-structure infections were randomized to receive cefditoren 200 or 400 mg, cefuroxime 250 mg, or cefadroxil 500 mg, each BID for 10 days. Study 1 compared cefditoren with cefuroxime; Study 2 compared cefditoren with cefadroxil. Clinical and microbiologic responses were assessed at a post-treatment visit (within 48 hours of treatment completion) and test-of-cure visit (7–14 days after treatment completion). Patients were monitored closely throughout the study with the use of physical examinations, clinical laboratory tests, and assessment of adverse events. Results: A total of 1685 patients (855 males, 830 females; mean age, 41.1 years [range, 12–95 years]) were enrolled. Within both studies, the 3 treatment groups were similar at baseline based on demographic characteristics and types of infection. Cellulitis (26%), wound infection (25%), and simple abscess (15%) were the most common infections. Clinical cure rates at the test-of-cure visit were 85% (443/523) for cefditoren 200 mg, 83% (427/516) for cefditoren 400 mg, 88% (234/265) for cefuroxime, and 85% (211/248) for cefadroxil. At the test-of-cure visit, cefditoren 200 mg had eradicated significantly fewer of the causative pathogens isolated before treatment in microbiologically evaluable patients than did cefuroxime in Study 1 (P = 0.043) but significantly more of the pathogens than did cefadroxil in Study 2 (P = 0.018). Eradication rates for the most commonly isolated pathogens were generally similar in the 3 treatment groups in both studies, with the only significant difference favoring cefditoren 200 and 400 mg over cefadroxil for Peptostreptococcus species in Study 2 (P = 0.016 and P = 0.003, respectively). A minority of patients (≤5% in any treatment group) discontinued study-drug treatment prematurely due to a treat