Vol.60 No.4 July 2012
An open clinical study of high-dose cefditoren pivoxil in children with bacterial pneumonia, acute otitis media, or acute rhinosinusitis
1)Kitasato Institute for Life Science, Kitasato University, 5-9-1 Shirokane, Minato-ku, Tokyo, Japan
2)Department of Pediatrics, Kawasaki Medical School
3)Department of Otolaryngology, The Second Hospital, Fujita Health University
4)Department of Infection Diseases and Infection Control, Jikei University School of Medicine
Abstract
The efficacy, safety, medication compliance, and pharmacokinetics of high-dose cefditoren pivoxil (CDTR-PI) in children with bacterial pneumonia, acute otitis media, or acute rhinosinusitis were investigated in a general clinical study. The dosage regimen was 6 mg/kg/dose t.i.d., administered orally after meals for a period of 7 days. In the efficacy analysis population (n=106), the clinical efficacy at the end of treatment (at the time of discontinuation) was 100% (14/14 subjects) for bacterial pneumonia, 89.9% (71/79 subjects) for acute otitis media, and 92.3% (12/13 subjects) for acute rhinosinusitis. The eradication rate of the causative organism at the end of treatment (at the time of discontinuation) was 88.5% (46/52 strains). The most frequently isolated causative organisms were Streptococcus pneumoniae and Haemophilus influenzae, at 24.1% (13/54 strains) and 61.1% (33/54 strains), respectively; thus these two organisms accounted for 85.2%. In the safety analysis population (n=115), the incidence of subjective symptoms and objective findings of adverse reactions were 31.3% (36/115 subjects). The incidence of abnormal laboratory data was 6.2% (7/113 subjects). The main adverse reactions were watery stools, mushy stools, and loose bowels, which were all forms of diarrhea. The only severe event was one event of watery stools, and there were no other serious adverse reactions. In the compliance analysis population (n=115), the drug was easy to take in 93.0% (107/115 subjects). Concerning the pharmacokinetics, a high T > MIC of over 70% was achieved in 37 of 40 subjects in the PK-PD analysis population, and 44 of 47 strains. Based on these results, we consider that CDTR-PI fine granules at a 6 mg/kg/dose t.i.d are useful for the treatment of pneumonia, acute otitis media, and acute rhinosinusitis in children, of which the major causative microorganisms, S. pneumoniae and H. influenzae, have become increasingly drug-resistant in recent years.
Key word
cefditoren pivoxil, high dose, acute otitis media, pneumonia, child
Received
February 22, 2012
Accepted
April 24, 2012
Jpn. J. Chemother. 60 (4): 478-491, 2012
