Unique ID issued by UMIN | UMIN000012791 |
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Receipt number | R000014946 |
Scientific Title | Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media |
Date of disclosure of the study information | 2014/01/08 |
Last modified on | 2018/09/25 14:46:11 |
Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Japan |
Bacterial pneumonia, Otitis media
Medicine in general | Pneumology | Infectious disease |
Pediatrics | Oto-rhino-laryngology |
Others
NO
To confirm the efficacy and safety of tosufloxacin granules in daily clinical practice and to reveal the following items
-Incidence of unknown adverse drug reactions
-Frequency of adverse drug reactions in daily clinical practice
-Factors likely to affect the safety and efficacy
Nausea/vomiting and joint disorders are intensively investigated
Safety,Efficacy
Phase IV
Clinical efficacy at the termination of tosufloxacin granules treatment (assessed by primary physician)
Bacteriological efficacy
Adverse drug reaction during the observation period
Observational
Not applicable |
15 | years-old | > |
Male and Female
Children (younger than 15 years)
Patients who have no previous medical history of tosufloxacin or who have not received tosufloxacin for more than 8 days since the end of the previous tosufloxacin treatment (to avoid registration of the patients with the same episode)
Patients who have a history of hypersensitivity to tosufloxacin
Patients who are pregnant or possibly pregnant
700
1st name | |
Middle name | |
Last name | Keisuke Sunakawa |
The Kitasato Institute, Kitasato University, Tokyo, Japan
Research Organization for Infection Control Sciences
5-9-1 Sirokane, Minato-ku, Tokyo,108-8641 Japan
03-3444-6161
sunakawa@med.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Satoru Kushimoto |
Toyama Chemical Co., Ltd.
Post-Marketing Surveillance Group, Data Science and Administration Department
2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo 160-0023, Japan
03-5381-3877
satoru_kushimoto@toyama-chemical.co.jp
Toyama Chemical Co., Ltd.
Toyama Chemical Co., Ltd.
Profit organization
NO
2014 | Year | 01 | Month | 08 | Day |
Published
http://www.chemotherapy.or.jp/journal/jjc/06202/062020204.pdf
There were a total of 760 patients included in the compliance analysis, 759 in the safety analysis, 688 in the efficacy analysis and 20 in the bacteriological efficacy analysis.
The incidence of adverse drug reactions (ADRs) was 2.77% (21/759), and the major ADRs were gastrointestinal disorders including diarrhea in 16 patients (2.11%). Nausea vomiting and joint disorders were intensively investigated. Vomiting was reported in 8 patients (1.05%), which was not clinically significant. No joint disorders were reported.
The overall efficacy rate was 98.1% (675/688). The efficacy rate by the type of infection was 100% (145/145) for bacterial pneumonia and 97.7% (506/518) for otitis media.
The eradication rates of Streptococcus pneumoniae and Haemophilus influenzae which are major causative or organisms
in pediatric infections of pneumonia and otitis media were 7/8 and 93.3% (14/15), respectively.
The compliance was good in 87.5% of the patients (665/760).
Completed
2009 | Year | 12 | Month | 25 | Day |
2010 | Year | 03 | Month | 01 | Day |
We did a presentation of this study at the 60th annual meeting of the Japanese Society of Chemotherapy.
2014 | Year | 01 | Month | 08 | Day |
2018 | Year | 09 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014946
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