UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041425
Receipt number R000047293
Scientific Title Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia in acute respiratory failure; systematic review and meta-analysis
Date of disclosure of the study information 2020/08/15
Last modified on 2020/08/15 15:26:54

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Basic information

Public title

Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia in acute respiratory failure; systematic review and meta-analysis

Acronym

Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia

Scientific Title

Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia in acute respiratory failure; systematic review and meta-analysis

Scientific Title:Acronym

Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia

Region

Japan


Condition

Condition

pneumonia, acute respiratory distress syndrome (ARDS), or respiratory failure

Classification by specialty

Pneumology Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The study aims to identify the diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic accuracy of cytomegalovirus antigenemia and polymerase chain reaction to detect the cytomegalovirus pneumonia

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

15 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

The target participants are as follows; 1) Adult patients who are 15 or more years old. 2) Presentation with pneumonia or acute respiratory failure.

Key exclusion criteria

Not perform histology, cytology, or viral tests to indetify cytomegalovirus pneumonia.

Target sample size



Research contact person

Name of lead principal investigator

1st name Masahiro
Middle name
Last name Katsurada

Organization

Hyogo Prefectural Tamba Medical Center

Division name

Internal Medicine

Zip code

6693495

Address

Iso 2002-7, Hikami-Cho, Tamba-City, Hyogo, Japan

TEL

+81-795-88-5200

Email

pgex309t@gmail.com


Public contact

Name of contact person

1st name Masahiro
Middle name
Last name Katsurada

Organization

Hyogo Prefectural Tamba Medical Center

Division name

Internal Medicine

Zip code

6693495

Address

Iso 2002-7, Hikami-Cho, Tamba-City, Hyogo, Japan

TEL

+81-795-88-5200

Homepage URL


Email

pgex309t@gmail.com


Sponsor or person

Institute

Hyogo Prefectural Tamba Medical Center

Institute

Department

Personal name



Funding Source

Organization

Hyogo Prefectural Tamba Medical Center

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

None

Address

None

Tel

None

Email

None


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

2020 Year 08 Month 15 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

Preinitiation

Date of protocol fixation

2020 Year 08 Month 15 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 20 Day

Last follow-up date

2022 Year 08 Month 19 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Participants: The target participants are pneumonia, ARDS or respiratory failure.

Target condition:CMV pneumonia

Setting:Any type of settings is included. (Pre-hospital, In-hospital, or Intensive Care Unit)

Index test:The index test being investigated is cytomegalovirus antigenemia in blood and polymerase chain reaction in BAL.

Reference standard:The reference standard is histological or cytological, or viral detection of cytomegalovirus in lung organization or bronchial lavage sample.


Management information

Registered date

2020 Year 08 Month 15 Day

Last modified on

2020 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047293


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name