Vol.65 No.4 July 2017

A phase III, randomized, open-label study on 15% tosufloxacin granules in pediatric Mycoplasma pneumoniae pneumonia

Kazunobu Ouchi¹⁾, Shinichiro Takayama²⁾, Yoshitake Fujioka³⁾, Keisuke Sunakawa^{† 4)} and Satoshi Iwata⁵⁾

¹⁾Department of Pediatrics, Kawasaki Medical School, 577 Matsushima, Kurashiki, Okayama, Japan
²⁾Department of Surgical Specialties, National Center for Child Health and Development
³⁾Clinical Research Department, Toyama Chemical Co., Ltd.
⁴⁾Formerly: Kitasato University Research Organization for Infection Control Sciences (†Deceased)
⁵⁾Department of Infectious Diseases, Keio University School of Medicine

Abstract

We conducted a randomized and open-label study to evaluate the efficacy and safety of tosufloxacin (TFLX) 6 mg/kg administered twice daily to children with Mycoplasma pneumoniae pneumonia.
The alleviation rate was 93.9% (31/33 patients) in the TFLX group and 80.0% (24/30 patients) in the clarithromycin (CAM) group. The efficacy rate was 97.0% (32/33 patients) in the TFLX group and 90.0% (27/30 patients) in the CAM group. The efficacy rate for patients who had macrolide-resistant M. pneumoniae pneumonia was 2/2 in the TFLX group and 2/2 in the CAM group. In the TFLX group, the eradication rate of M. pneumoniae was 4/4 for patients with M. pneumoniae and 2/2 for macrolide-resistant M. pneumoniae. In the CAM group, the eradication rate of M. pneumoniae was 3/5 for patients with M. pneumoniae and 0/2 for macrolide-resistant M. pneumoniae.
In the TFLX group, the incidence of adverse events was 66.7% (22/33 patients) and of adverse drug reactions was 15.2% (5/33 patients). The most common adverse events were nasopharyngitis (15.2%) and upper respiratory tract inflammation (15.2%). No serious adverse events were reported. In the CAM group, the incidence of adverse events was 66.7% (20/30 patients) and of adverse drug reactions was 10.0% (3/30 patients). The most common adverse events were diarrhea (13.3%), vomiting (10.0%), gastroenteritis (10.0%), and rhinorrhea (10.0%). One serious adverse event was reported in the CAM group, and was considered related to CAM administration. One joint-related adverse event was reported in both groups, and both cases were considered unrelated to TFLX or CAM.
These results showed that TFLX was comparable in its efficacy to CAM, better in its safety than CAM, and offered good bacteriological efficacy. TFLX is useful for the treatment of pediatric patients with M. pneumoniae.

Key word

tosufloxacin, child, Mycoplasma pneumoniae

Received

January 19, 2017

Accepted

March 1, 2017

Jpn. J. Chemother. 65 (4): 585-596, 2017