UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013321
Receipt number 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 22:04:41

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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 or person

Institute

Society for the Use of Quinolones in Children

Institute

Department

Personal name



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

Value
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