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 | 2025/02/17 09:40:29 |
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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
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
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
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
Terminated
Date of protocol fixation
| 2020 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 15 | Day |
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
| 2025 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047293
