UMIN-CTR Clinical Trial

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
Email	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
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	Hokkaido University Certified Review Board
Address	Kita-14, Nishi-5, Kita-ku, Sapporo
Tel	011-706-7934
Email	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	Enrolling by invitation
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 03 Month 31 Day
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	2020 Year 10 Month 21 Day

Link to view the page
URL(English)	https://center6.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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