UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021152
Receipt number R000024318
Scientific Title Viral load of varicella-zoster virus in a private room of patient with lesions of varicella or zoster
Date of disclosure of the study information 2016/02/23
Last modified on 2016/02/23 08:51:50

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Basic information

Public title

Viral load of varicella-zoster virus in a private room of patient with lesions of varicella or zoster

Acronym

Viral load of varicella-zoster virus in a private room of patient with lesions of varicella or zoster

Scientific Title

Viral load of varicella-zoster virus in a private room of patient with lesions of varicella or zoster

Scientific Title:Acronym

Viral load of varicella-zoster virus in a private room of patient with lesions of varicella or zoster

Region

Japan


Condition

Condition

Varicella, shingles, Disseminated zoster

Classification by specialty

Medicine in general Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To consider whether we need isolated room or not to manage patients with shingles and varicella by measuring viral load of VZV in their rooms and the outside.

Basic objectives2

Others

Basic objectives -Others

Observation

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

The association between viral load in atmosphere of VZV and clinical feature of VZV infection or underlying diseases

Key secondary outcomes

The association between viral load in atmosphere of VZV and viral shedding from throat


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patient with active varicella or zoster who is admitted to private room of hospital

Key exclusion criteria

We exclude patient
who rejects to join in this study,
or who started taking anti-VZV agents over 5 days ago,
or who have already joined in this study,
or who is revealed that don't VZV infection by further test

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norio Ohmagari

Organization

National Center for Global Health and Medicine

Division name

Disease control and prevention center

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Email

lukenorioom@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Kei Yamamoto

Organization

National Center for Global Health and Medicine

Division name

Disease control and prevention center

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo

TEL

03-3202-7181

Homepage URL


Email

nicepoko@gmail.com


Sponsor or person

Institute

National Center for Global Health and Medicine

Institute

Department

Personal name



Funding Source

Organization

National Center for Global Health and Medicine

Organization

Division

Category of Funding Organization

Other

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 02 Month 23 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

Open public recruiting

Date of protocol fixation

2015 Year 07 Month 21 Day

Date of IRB


Anticipated trial start date

2015 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Design: Prospective observational study
Duration: 1 October 2015 to 31 July 2017
Patients who has infection due to varicella zoster virus, and who are hospitalized in private room, and whose rash and vesicle have appeared within 5 days.
Patient characteristics are reviewed by clinical board as following: age, sex, underlying diseases, chemotherapy, immunosuppressants, clinical features, white blood cell counts, treatment for varicella zoster virus infection


Management information

Registered date

2016 Year 02 Month 23 Day

Last modified on

2016 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name