UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017316 |
|---|---|
| Receipt number | R000020095 |
| Scientific Title | Review of clinical manifestation and diagnosis(real-time PCR, LAMP) in Pertussis |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/04/28 21:23:37 |
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Basic information
Public title
Review of clinical manifestation and diagnosis(real-time PCR, LAMP) in Pertussis
Acronym
Review of pertussis
Scientific Title
Review of clinical manifestation and diagnosis(real-time PCR, LAMP) in Pertussis
Scientific Title:Acronym
Review of pertussis
Region
| Japan |
Condition
Condition
Pertussis
Classification by specialty
| Infectious disease | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate for association between clinical manifestation and diagnosis of pertussis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
concordance rate for anti-PT IgG and PCR
Key secondary outcomes
To make score of clinical manifestation to diagnose pertussis
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
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Present any symptoms(cough for 2 weeks, staccato cough, Wooping, vomiting with cough, apnea, cyanosis) and physician suspects pertussis
Key exclusion criteria
disagree with real-time PCR and LAMP
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuho Horikoshi |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of infectious diseases
Zip code
Address
Musashidai2-8-29, Huchu city, Tokyo, Japan
TEL
042-300-5111
mihoko.isogai@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mihoko Isogai |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Division of infectious diseases
Zip code
Address
Musashidai2-8-29, Huchu city, Tokyo, Japan
TEL
042-300-5111
Homepage URL
mihoko.isogai@gmail.com
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Children's Medical Center
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
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
| 2015 | Year | 05 | Month | 01 | 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
no data
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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
clinical manifestation, vital signs, laboratory data, treatment
Management information
Registered date
| 2015 | Year | 04 | Month | 28 | Day |
Last modified on
| 2015 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020095
