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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024458
Receipt No. 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 2017/04/19

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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
Middle name
Last name Nobuhisa Ishiguro
Organization Hokkaido University Hospital
Division name Infection Control Team
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo
TEL 011-706-5703
Email nishigur@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhisa Ishiguro
Organization Hokkaido University Hospital
Division name Infection Control Team
Zip code
Address Kita-14, Nishi-5, Kita-ku, Sapporo
TEL 011-706-5703
Homepage URL
Email nishigur@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 09 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
2016 Year 10 Month 18 Day
Last modified on
2017 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027881

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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