UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012791
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

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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 or person

Institute

Toyama Chemical Co., Ltd.

Institute

Department

Personal name



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

Value
https://center6.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