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UMIN-CTR Clinical Trial |
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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 | 2020/10/21 |
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 |
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Condition | ||
Condition | Individuals who shared a room with the index patient infected with influenza. | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 279 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |