UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Title of the study (Brief title)	Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Region	Japan

Condition
Condition	Bacterial pneumonia, Otitis media
Classification by specialty	Medicine in general Pneumology Infectious disease Pediatrics Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	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
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

Assessment
Primary outcomes	Clinical efficacy at the termination of tosufloxacin granules treatment (assessed by primary physician) Bacteriological efficacy Adverse drug reaction during the observation period
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	15 years-old >
Gender	Male and Female
Key inclusion criteria	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)
Key exclusion criteria	Patients who have a history of hypersensitivity to tosufloxacin Patients who are pregnant or possibly pregnant
Target sample size	700

Research contact person
Name of lead principal investigator	Keisuke Sunakawa
Organization	The Kitasato Institute, Kitasato University, Tokyo, Japan
Division name	Research Organization for Infection Control Sciences
Address	5-9-1 Sirokane, Minato-ku, Tokyo,108-8641 Japan
TEL	03-3444-6161
Email	sunakawa@med.kitasato-u.ac.jp

Public contact
Name of contact person	Satoru Kushimoto
Organization	Toyama Chemical Co., Ltd.
Division name	Post-Marketing Surveillance Group, Data Science and Administration Department
Address	2-5, Nishishinjuku 3-chome, Shinjuku-ku, Tokyo 160-0023, Japan
TEL	03-5381-3877
Homepage URL
Email	satoru_kushimoto@toyama-chemical.co.jp

Sponsor
Institute	Toyama Chemical Co., Ltd.
Institute
Department

Funding Source
Organization	Toyama Chemical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2014 Year 01 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 12 Month 25 Day
Anticipated trial start date	2010 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.chemotherapy.or.jp/journal/jjc/06202/062020204.pdf
Results	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).
Other related information	We did a presentation of this study at the 60th annual meeting of the Japanese Society of Chemotherapy.

Management information
Registered date	2014 Year 01 Month 08 Day
Last modified on	2018 Year 09 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014946