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Randomized, Double-Blind, Multicenter Comparison of Oral CLINICAL THERAPEUTICS®/VOL. 24, NO. 7, 2002 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 Alicia D. Bucko, DO, 1 Barbara J. Hunt, MS,2 Sarah L. Kidd, BS,2 and Richard Hom, MD, PhD z 1Academic Dermatology Associates, Albuquerque, New Mexico, and 2TAP Pharmaceutical Products Inc, Lake Forest, Illinois ABSTRACT Background: Uncomplicated skin and skin-structure infections are commonly ob- served in medical practice. Because these infections typically are confined to the super- ficial 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 microbio- logic activity against gram-positive pathogens. Objective: This paper compares the efficacy and tolerability of 3 beta-lactam antibi- otics 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 ran- domized 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. Clin- ical cure rates at the test-of-cure visit were 85% (443/523) for cefditoren 200 rag, 83% Presented in part at the 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, September 17-20, 2000, Toronto, Ontario, Canada. Accepted for publication April 24, 2002. Printed in the USA. Reproduction in whole or part is not permitted, 1134 0149-2918/02/$19.00 A.D. BUCK0 ET AL. (427/516) for cefditoren 400 mg, 88% infections, and simple abscesses, are com- (234/265) for cefuroxime, and 85% monly encountered in ambulatory set- (21 l/248) for cefadroxil. At the test-of- tings.’ Staphylococcus aureus, group A cure visit, cefditoren 200 mg had eradi- streptococci (ie, Streptococcus pyogenes), cated significantly fewer of the causative and occasionally other beta-hemolytic pathogens isolated before treatment in mi- streptococci cause most of these infec- crobiologically evaluable patients than did tions, although gram-negative organisms cefuroxime in Study 1 (P = 0.043) but sig- (eg, Pseudomonas aeruginosa, Esch- nificantly more of the pathogens than did erichia co/i) are also isolated.2 Because cefadroxil in Study 2 (P = 0.018). Eradi- uncomplicated skin and skin-structure in- cation rates for the most commonly iso- fections typically are confined to the su- lated pathogens were generally similar in perficial layers and seldom lead to the de- the 3 treatment groups in both studies, with struction of skin structures and resultant the only significant difference favoring systemic dissemination, in general they cefditoren 200 and 400 mg over cefadroxil can be treated with an oral antibiotic with for Peptostreptococcus species in Study 2 potent microbiologic activity against (P = 0.016 and P = 0.003, respectively). A gram-positive pathogens. In select cases, minority of patients (1.5% in any treatment local dibridement or incision and drainage group) discontinued study-drug treatment also are used to facilitate cure. prematurely due to a treatment-related ad- Among the antimicrobial agents used verse event, with statistically higher rates for treating uncomplicated skin and skin- for cefditoren 400 mg than for cefditoren structure infections, beta-lactams provide 200 mg and the comparator cephalosporins excellent coverage of methicillin-susceptible (each P < 0.05). All 3 cephalosporins were S aureus and streptococci. Oral beta-lactam generally well tolerated. Most adverse agents with proven clinical efficacy for events (~93%) were categorized as mild uncomplicated skin and skin-structure in- to moderate, with the most common being fections include cefprozil, cefpodoxime diarrhea, nausea, and headache. proxetil, cefuroxime axetil, cefadroxil mono- Conclusion: In this population of pa- hydrate, and penicillin-beta-lactamase tients with uncomplicated skin and skin- inhibitor combinations (eg, amoxicillin/ structure infections, including those due clavulanate).‘-6 to Staphylococcus aureus or Streptococcus Cefditoren pivoxil is an oral, beta- pyogenes, the clinical cure rate and toler- lactamase-stable cephalosporin with bal- ability of cefditoren were comparable to anced in vitro activity against both gram- those of cefuroxime and cefadroxil. positive and gram-negative organisms?-” Key words: cefditoren, cefadroxil, cef- In particular, it possesses excellent in vitro uroxime, skin and soft tissue infection. activity against S aureus (minimum in- (C&z Ther. 2002;24: 1134-l 147) hibitory concentration [MIC] at which 90% of isolates are inhibited [MIC,,] = 0.5 pg/mL) and Spyogenes (MIC,, = 0.03 INTRODUCTION pg/mL).9 After oral administration, cef- Uncomplicated skin and adjacent skin- ditoren pivoxil is absorbed by the gas- structure infections, including impetigo, trointestinal tract and hydrolyzed to cef- erysipelas, cellulitis, folliculitis, wound ditoren by esterases. The maximal plasma 1135 CLINICAL THERAPEUTICS ® concentration of cefditoren averages legal guardians provided written informed 2.60 ± 0.65/~g/mL after a single 200-mg consent. dose and occurs 1.5 to 3.0 hours after dos- ing. Maximal concentrations of cefditoren Patients in blister fluid were observed 4 to 6 hours after administration of a 400-rag dose of Eligible patients included those aged cefditoren pivoxil, with a mean of 1.1 ± >12 years with mild to moderate uncom- 0.42 p g/mL.l 2 Mean cefditoren concentra- plicated skin or skin-structure bacterial tions in blister fluid at 12 hours after dos- infections that could be treated with an ing exceed 0.4/~g/mLJ 2 Because experi- oral antimicrobial agent. Eligible patients mental data with beta-lactams suggest that had at least 2 of the following local signs time above the MIC is related to outcome and symptoms: pain, tenderness, swelling, of infection 13 and concentrations of cefdi- erythema, associated warmth, purulent toren achieved in skin blister fluid exceed drainage/discharge, induration, and re- its MIC90 for the common gram-positive gional lymph node swelling or tenderness. skin pathogens over most of the 12-hour Women of childbearing potential were re- dosing interval, cefditoren is expected to quired to have a negative result of a have good clinical activity for treating skin prestudy serum or urine pregnancy test infections. In vitro data cannot substitute and agreed to use effective contraception for in vivo clinical data in humans. throughout the study. This article presents the results of 2 In addition to pregnancy or lactation, clinical trials that were designed to com- study exclusion criteria included a chronic pare the efficacy and tolerability of cefdi- or underlying skin condition at the site of toren with those of 2 comparator ceph- the infection(s) involving prosthetic mate- alosporins, cefuroxime and cefadroxil, rials; a wound caused by thermal injury or in patients with uncomplicated skin and acne vulgaris; a site that required surgical skin-structure infections. intervention; abscesses in an anatomic site at high risk for anaerobic infection (eg, rectal area); concomitant documented or PATIENTS AND METHODS suspected bacteremia; infections of the Study Design nail beds and scalp, as well as isolated fu- runculosis or folliculitis; immunodefi- Both multicenter studies (69 sites in the ciency; diabetes mellitus; significant vas- cefadroxil study and 63 sites in the cefur- cular disease; concomitant treatment with oxime study) were conducted in a double- oral or parenteral antibiotics or topical blind, randomized manner. The studies' agents (eg, corticosteroids or antimicro- protocols and procedures followed guide- bials) at the infection site; history of hy- lines established by the Infectious Dis- persensitivity reactions to beta-lactam eases Society of America and the US Food agents; known renal insufficiency (serum and Drug Administration for the evalua- creatinine concentration >2 mg/dL or tion of anti-infective agents. 14 Before pa- blood urea nitrogen >30 mg/dL); and clin- tient enrollment, the institutional review ically significant hepatic disease (alanine board of each site approved the study pro- aminotransferase, aspartate aminotrans- tocol, and all participating patients or their ferase, or total bilirubin >2 times the up- 1136 A.D. BUCKO ET AL. per limit of normal or alkaline phos- visits conducted at regular intervals phatase >1.25 times the upper limit of throughout the 2 studies: (1) before the normal). Exclusion criteria also included start of dosing on the first study day, (2) the use of a systemic antibiotic within
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