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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000013321
Receipt No. R000015538
Scientific Title Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children
Date of disclosure of the study information 2014/04/01
Last modified on 2014/03/03

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Basic information
Public title Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children
Acronym Efficacy and safety of TFLX fine granules for the treatment of CAP in children
Scientific Title Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children
Scientific Title:Acronym Efficacy and safety of TFLX fine granules for the treatment of CAP in children
Region
Japan

Condition
Condition Community-acquired pneumonia
Classification by specialty
Medicine in general Pneumology Infectious disease
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy, bacteriological efficacy, and safety of TFLX fine granules in children with CAP
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical efficacy at the end of the treatment
Bacteriological efficacy at the end of the treatment
Adverse drug reactions
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TFLX tosilate hydrate was orally administered at a dose of 6 mg/kg (4.1 mg/kg of TFLX) BID for 5 to 10 days. The maximum dosage of TFLX tosilate hydrate did not exceed 180 mg/dose and 360mg/day (122.4 mg/dose and 224.8mg/day of TFLX).
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
16 years-old >
Gender Male and Female
Key inclusion criteria Patients with mild to severe CAP based on the severity assessment criteria in the Guidelines for the Management of Respiratory Infectious Diseases in Children in Japan 2007.
Patients younger than 16 years.
Key exclusion criteria Patients who are not expected to recover by oral antimicrobial agents or those with urinary-tract infection.
Patients who cannot take oral medications or those who refuse to take any drug.
Patients who have a history of allergy to quinolone antibacterial agents.
Patients who received antimicrobial agents before treatment with TFLX fine granules and whose conditions are improving.
Patients who are suspected of having viral pneumonia or other diseases which are not expected to be resolved by TFLX fine granules.
Other patients whom the physician deems to be ineligible for any reason.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Sunakawa
Organization Kitasato University
Division name Research Organization for Infection Control Sciences
Zip code
Address 5-9-1, Shirokane, 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 Hiroshi Sakata
Organization Asahikawa Kosei Hospital
Division name Department of Pediatrics
Zip code
Address 24-111, Ichijo-dori, Asahikawa, Hokkaido, Japan
TEL 0166-33-7171
Homepage URL
Email sakhiro@mac.com

Sponsor
Institute Society for the Use of Quinolones in Children
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2010 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 03 Day
Last modified on
2014 Year 03 Month 03 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015538

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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