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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012791
Receipt No. 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

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Basic information
Public title Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Acronym Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Scientific Title Evaluation of the safety and efficacy of tosufloxacin granules for pediatric with bacterial pneumonia, otitis media
Scientific Title:Acronym 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
1st name
Middle name
Last name Keisuke Sunakawa
Organization The Kitasato Institute, Kitasato University, Tokyo, Japan
Division name Research Organization for Infection Control Sciences
Zip code
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
1st name
Middle name
Last name Satoru Kushimoto
Organization Toyama Chemical Co., Ltd.
Division name Post-Marketing Surveillance Group, Data Science and Administration Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.chemotherapy.or.jp/journal/jjc/06202/062020204.pdf
Number of participants that the trial has enrolled
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 12 Month 25 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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