UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024458 |
|---|---|
| Receipt number | R000027881 |
| Scientific Title | Multicenter prospective single-group study of three-day regimen of oseltamivir (Tamiflu) for postexposure prophylaxis. |
| Date of disclosure of the study information | 2016/10/31 |
| Last modified on | 2024/10/23 12:16:48 |
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Basic information
Public title
Multicenter prospective single-group study of three-day regimen of oseltamivir (Tamiflu) for postexposure prophylaxis.
Acronym
Three-day regimen of oseltamivir for postexposure prophylaxis.
Scientific Title
Multicenter prospective single-group study of three-day regimen of oseltamivir (Tamiflu) for postexposure prophylaxis.
Scientific Title:Acronym
Three-day regimen of oseltamivir for postexposure prophylaxis.
Region
| Japan |
Condition
Condition
Individuals who shared a room with the index patient infected with influenza.
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, index patients who developed influenza during hospitalization were transferred to isolation rooms, and individuals who shared a room with the index patient are administered oseltamivir for three
days as postexposure prophylaxis. The aim of this study is to analyse the effectiveness of a three-day regimen of oseltamivir.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome of this study is occurrence of influenza infection after a three-day regimen of oseltamivir as postexposure prophylaxis. Individuals who shared a room with the index patient infected with influenza were monitored for influenza-like symptoms for seven days after postexposure prophylaxis.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Individuals who shared a room with the influenza patient with a positive immuno-chromatographic test were given oseltamivir for three days as post-exposure prophylaxis.
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 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patiets older than one year of age.
2. Individuals who shared a room with influenza patient (index case) with a positive immuno-chromatographic test were immediately separated from the index case by transferring to isolation room.
3. Oseltamivir for post-exposure prophylaxis was started within 48 hours after the onset of fever in the index case.
4. Written informed consent was obtained from each patient before enrolment.
Key exclusion criteria
1. Patients with renal insufficiency (creatinine clearance less than 30 mL/min).
2. Patients older than 10 years and younger than 20 years.
3. Any other patients who are regarded as unsuitable for this study by the investigator.
Target sample size
279
Research contact person
Name of lead principal investigator
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Ishiguro |
Organization
Hokkaido University Hospital
Division name
Infection Control Team
Zip code
060-8648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo
TEL
011-706-5703
nishigur@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Nobuhisa |
| Middle name | |
| Last name | Ishiguro |
Organization
Hokkaido University Hospital
Division name
Infection Control Team
Zip code
060-8648
Address
Kita-14, Nishi-5, Kita-ku, Sapporo
TEL
011-706-5703
Homepage URL
nishigur@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Certified Review Board
Address
Kita-14, Nishi-5, Kita-ku, Sapporo
Tel
011-706-7934
recjimu@huhp.hokudai.ac.jp
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
| 2016 | Year | 10 | Month | 31 | 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
| 2016 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 07 | Month | 04 | Day |
Date trial data considered complete
| 2024 | Year | 07 | Month | 04 | Day |
Date analysis concluded
| 2024 | Year | 07 | Month | 04 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027881
