UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007328 |
|---|---|
| Receipt number | R000008639 |
| Scientific Title | The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study. |
| Date of disclosure of the study information | 2012/02/21 |
| Last modified on | 2013/08/23 19:22:43 |
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Basic information
Public title
The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study.
Acronym
The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old).
Scientific Title
The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old): an open-label,non-randomized, multi-centre study.
Scientific Title:Acronym
The clinical effects of peramivir on influenza virus infections in infants (age; over 28 days old, under 4 years old).
Region
| Japan |
Condition
Condition
Infants with Influenza virus infections.
Classification by specialty
| Medicine in general | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical and virology effects of peramivir on influenza virus (Sub-types; A/H1N1pdm09, A/H3N2, B) in infants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to return to normal body temperature (under 37.5 degrees).
Key secondary outcomes
Ratio of influenza virus-positive patients.
Virus mutation after treatment of peramivir.
Duration of influenza symptoms.
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
| 1 | months-old | <= |
Age-upper limit
| 48 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Guardian of the patients with informed consent.
Gender: Male or female.
In patients or Out patients.
Age: over 28 days old, under 4 years old.
Patient who must be use to intravenous peramivir for the following: Can't use oral or inhaler medicines, dehydration, chronic diseases, severe symptoms, etc,.
Key exclusion criteria
History of hypersensitivity caused by neuraminidase inhibitors. Patients who are deemed to be inappropriate by the investigator.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Takasaki |
Organization
Takasaki Pediatric Clinic
Division name
Pediatrics
Zip code
Address
4-14-33 Shimoyamato, Nishi-ku, Fukuoka, 819-0052, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Takasaki Pediatric Clinic
Division name
Pediatrics
Zip code
Address
4-14-33 Shimoyamato, Nishi-ku, Fukuoka, 819-0052, Japan
TEL
Homepage URL
Sponsor or person
Institute
Takasaki Pediatric Clinic
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
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
高崎小児科医院（福岡県）、しんどう小児科医院（福岡県）、横山小児科医院（福岡県）、やました小児科医院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2012 | Year | 02 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 10 | Month | 15 | Day |
Other
Other related information
An open-label, non-randomized, multi-centre study.
Observe fever and symptoms.
Nasal/Throat swabs in fluid for virology.
Management information
Registered date
| 2012 | Year | 02 | Month | 19 | Day |
Last modified on
| 2013 | Year | 08 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008639
