The special drug use surveillance of INAVIR for inhalation suspension set (Safety evaluation in pediatric patients under five years old)
Not Applicable
Completed
- Conditions
- Influenza virus infection
- Registration Number
- JPRN-jRCT1080224937
- Lead Sponsor
- DAIICHI SANKYO CO., LTD.
- Brief Summary
The results of this surveillance verified that there are no noticeable problems with the safety or efficacy of laninamivir for children under the age of 5 infected with the influenza A and B viruses.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1156
Inclusion Criteria
1) Patients had not been treated with INAVIR for inhalation suspension set in the same influenza season.
2) Children under five years old
3) Patients had been diagnosed by a participating physician as being influenza virus infection positive based on a rapid diagnosis kit.
4) Patients were not suspected of primary or secondary infection with pathogenic microorganisms(viruses/bacteria)other than the influenza virus.
5) Patients obtained written informed consent from their guardians.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Incidence of adverse drug reactions
- Secondary Outcome Measures
Name Time Method efficacy<br>Duration to fever resolution<br>Duration to relief from influenza symptoms