Cefditoren pivoxil versus cefpodoxime proxetil for community-acquired pneumonia: Results of a multicenter, prospective, randomized, double-blind study

• Published in: Clinical therapeutics 2002-11, Vol.24 (11), p.1840-1853
• Main Authors: van Zyl, Louis, Le Roux, Jacobus G., Lafata, John A., Scott Volk, R., Palo, William A., Flamm, Robert, Hom, Richard C.
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - pharmacology; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Biological and medical sciences; CAP; cefditoren; cefpodoxime; Cefpodoxime Proxetil; Ceftizoxime - adverse effects; Ceftizoxime - analogs & derivatives; Ceftizoxime - pharmacology; Ceftizoxime - therapeutic use; Cephalosporins - adverse effects; Cephalosporins - pharmacology; Cephalosporins - therapeutic use; Child; Community-Acquired Infections - drug therapy; Community-Acquired Infections - microbiology; community-acquired pneumonia; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Medical sciences; Microbial Sensitivity Tests; Middle Aged; Pharmacology. Drug treatments; Pneumonia, Pneumococcal - drug therapy; Pneumonia, Pneumococcal - microbiology; Prospective Studies; South Africa; Streptococcus pneumoniae - drug effects; Streptococcus pneumoniae - isolation & purification; Treatment Outcome; United States
• ISSN: 0149-2918; 1879-114X
• DOI: 10.1016/S0149-2918(02)80083-2

Background: According to recently issued treatment guidelines, appropriate empiric choices for ambulatory patients with community-acquired pneumonia (CAP) are a macrolide, doxycycline (for patients aged ≥8 years), or an oral beta-lactam agent with good activity against pneumococci. Objective: This study was designed to compare cefditoren pivoxil, a new beta-lactam, with cefpodoxime proxetil, a beta-lactam with an established role in the treatment of CAP. Methods: This was a multicenter, prospective, randomized, double-blind study conducted in the United States and South Africa. Ambulatory patients with a diagnosis of CAP were randomized to 14 days of treatment with cefditoren 200 or 400 mg BID or cefpodoxime 200 mg BID. Assessments of clinical cure and pathogen eradication were conducted at 2 visits during treatment, 1 posttreatment visit ( ≤48 hours after completion of treatment), and 1 follow-up visit (7–14 days after completion of treatment). The development of resistant pathogens was assessed at the follow-up visit but not thereafter. The relative cost of treatment was not assessed. Results: The study enrolled 851 patients. Comparable clinical cure rates were observed among evaluable patients in the 3 treatment groups at both the posttreatment and follow-up visits: at the posttreatment visit, cure rates were 90.5% (162/179) for cefditoren 200 mg, 89.7% (148/165) for cefditoren 400 mg, and 92.2% (153/166) for cefpodoxime 200 mg; at the follow-up visit, they were a respective 88.4% (160/181), 87.2% (143/164), and 90.4% (151/167). Of the 171 strains of Streptococcus pneumoniae isolated before treatment, 22 (12.9%) had reduced susceptibility to penicillin, 5 (2.9%) of them penicillin resistant (minimum inhibitory concentration ≥2 μg/mL). At the posttreatment visit, the overall eradication rates of pathogens isolated from microbiologically evaluable patients were 88.7% (134/151), 89.9% (134/149), and 95.7% (134/140) in the respective treatment groups ( P = 0.031, cefditoren 200 mg vs cefpodoxime). Eradication rates of S pneumoniae were 93.8% (45/48), 95.7% (45/47), and 95.6% (43/45) in the respective treatment groups; those of Haemophilus influenzae were 90.2% (46/51), 97.7% (43/44), and 97.4% (37/38). The rates of resolution and/or improvement in clinical signs and symptoms were comparable between groups. The study drugs were well tolerated, with 1.7%, 2.5%, and 1.4% of patients in the respective groups discontinuing study drug prematurely due to a treatme