Unique ID issued by UMIN | UMIN000013321 |
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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 |
Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children
Efficacy and safety of TFLX fine granules for the treatment of CAP in children
Efficacy and safety of tosufloxacin tosilate hydrate for the treatment of community-acquired pneumonia in children
Efficacy and safety of TFLX fine granules for the treatment of CAP in children
Japan |
Community-acquired pneumonia
Medicine in general | Pneumology | Infectious disease |
Pediatrics |
Others
NO
To evaluate the clinical efficacy, bacteriological efficacy, and safety of TFLX fine granules in children with CAP
Safety,Efficacy
Clinical efficacy at the end of the treatment
Bacteriological efficacy at the end of the treatment
Adverse drug reactions
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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).
Not applicable |
16 | years-old | > |
Male and Female
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.
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.
100
1st name | |
Middle name | |
Last name | Keisuke Sunakawa |
Kitasato University
Research Organization for Infection Control Sciences
5-9-1, Shirokane, Minato-ku, Tokyo 108-8641, Japan
03-3444-6161
sunakawa@med.kitasato-u.ac.jp
1st name | |
Middle name | |
Last name | Hiroshi Sakata |
Asahikawa Kosei Hospital
Department of Pediatrics
24-111, Ichijo-dori, Asahikawa, Hokkaido, Japan
0166-33-7171
sakhiro@mac.com
Society for the Use of Quinolones in Children
none
Self funding
NO
2014 | Year | 04 | Month | 01 | Day |
Published
Completed
2010 | Year | 08 | Month | 11 | Day |
2010 | Year | 10 | Month | 08 | Day |
2014 | Year | 03 | Month | 03 | Day |
2014 | Year | 03 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015538
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