Vol.58 No.S-2 October 2010
An uncontrolled, open label study of tosufloxacin granules 10% in pediatric acute otitis media (AOM)
1)Department of Otolaryngology, Second Hospital, Fujita Health University, School of Medicine, 3-6-10 Otobashi, Nakagawa-ku, Nagoya, Aichi, Japan
2)Department of Otolaryngology, Jichi Medical University Saitama Medical Center
3)Department of Nutrition, Faculty of Health Care Science, Chiba Prefecture University of Health Science
4)Department of Otolaryngology, National Center for Child Health and Development
5)Department of Research Project Studies, Kitasato Institute for Life Sciences, Kitasato University
Abstract
We evaluated the efficacy, safety, and compliance of tosufloxacin(TFLX), a new quinolone antibacterial agent, 4 mg/kg or 6 mg/kg twice daily in the treatment of pediatric acute bacterial otitis media. The plasma concentration of TFLX was also measured.
Clinical efficacy posttreatment was 97.7% (125/128) in the 4 mg/kg b. i. d. group and 94.1% (32/34) in the 6 mg/kg b.i.d. group. Overall clinical efficacy was 96.9% (157/162). Despite risk factors such as group nursing or severity of infection or previous antimicrobial treatment, clinical efficacy was high.
Streptococcus pneumoniae and Haemophilus influenzae were mainly detected as the causative bacteria. Overall bacteriological eradication including resistant strains, such as Penicillin intermediately resistant S. pneumoniae(PISP), Penicillin resistant S. pneumoniae(PRSP) and β-lactamase non-producing ampicillin resistant H. influenzae(BLNAR), posttreatment was 99.0% (97/98). Recurrence within 2 weeks after treatment completion was 7.0% (10/142). The proportion of subjects finding medication "very easy to take" or "easy to take" was 97.7% (168/172).
The 165 adverse events were observed in 102 subjects and the incidence was 59.3% (102/172). The 48 drug-related adverse events were observed in 34 subjects and the incidence was 19.8% (34/172). Main adverse events were diarrhea (14/172; 8.1%), and vomiting (11/172; 6.4%). Although 3 adverse events of arthrosis (2 arthralgia and 1 contusion) were observed in 3 subjects, there was no relation to TFLX.
These results suggest that TFLX granules can be used to treat resistant-strain acute bacterial otitis media in pediatric subjects.
Key word
tosufloxacin, child, acute otitis media
Received
May 18, 2010
Accepted
September 7, 2010
Jpn. J. Chemother. 58 (S-2): 50-68, 2010
