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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039210
Receipt No. R000044703
Scientific Title Study on the effects of a molecular meningitis/encephalitis panel test for central nervous system infection
Date of disclosure of the study information 2020/01/22
Last modified on 2020/04/03

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Basic information
Public title Study to investigate whether drugs for infectious diseases such as meningitis are properly used by tests that can detect many microorganisms at the same time
Acronym Study on tests used for infectious diseases such as meningitis
Scientific Title Study on the effects of a molecular meningitis/encephalitis panel test for central nervous system infection
Scientific Title:Acronym Study on the effects of a molecular meningitis/encephalitis panel test
Region
Japan

Condition
Condition central nervous system infection, encephalitis, meningitis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 For patients with suspected central nervous system infection, we perform molecular meningitis/encephalitis panel test to identify the causative organism.
We investigate whether the results will change the durations and vials of antimicrobial agents (acyclovir and antibiotics), the length of stay, and length of stay in the intensive care unit.
We investigate whether this test is consistent with conventional cerebrospinal fluid culture and HSV-DNA test using high-sensitivity PCR.
We conduct an epidemiological survey on the causative microorganisms of patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of use of acyclovir for subjects
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 We use the remaining 200 micro L of the cerebrospinal fluid with written, informed consent from patient or patients' parents between January 2020 and March 2021.
We perform molecular meningitis/encephalitis panel test to identify the causative organism within 72 hours. The results of tests will be disclosed to the attending physician. The attending physician determines whether to start, continue, or discontinue acyclovir and antibiotics based on the results of molecular meningitis/encephalitis panel test, the patient's general condition, and other test results.
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
15 years-old >=
Gender Male and Female
Key inclusion criteria Patients admitted to our institution due to fever, disturbance of consciousness, or convulsions, who were suspected of meningitis or acute encephalitis and underwent a HSV-DNA test of cerebrospinal fluid using high-sensitivity PCR
Key exclusion criteria Patients who have solid tumors, hematologic malignancies, primary immunodeficiency, cystic fibromatosis as underlying diseases
Patients who are treated with long-term steroids or immunosuppressants
Patients who could not be performed molecular meningitis/encephalitis panel test within 72 hours after collection of CSF specimen.
Patients who have not given consent to sample collection and study from the patient or the patients' parents
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Kasai
Organization Hyogo Prefectural Kobe Children's Hospital
Division name Division of Infectious Disease
Zip code 650-0047
Address 1-6-7, Minato-Jima Minami-Machi, Kobe-shi Chuo-Ku, Hyogo, Japan
TEL +81-78-945-7300
Email kyashii55@gmail.com

Public contact
Name of contact person
1st name Shogo
Middle name
Last name Otake
Organization Hyogo Prefectural Kobe Children's Hospital
Division name Division of Infectious Disease
Zip code 650-0047
Address 1-6-7, Minato-Jima Minami-Machi, Kobe-shi Chuo-Ku, Hyogo, Japan
TEL +81-78-945-7300
Homepage URL
Email shogo.ohtake@gmail.com

Sponsor
Institute Hyogo Prefectural Kobe Children's Hospital
Institute
Department

Funding Source
Organization Japanese Society for Pediatric Infectious Diseases
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 Hyogo Prefectural Kobe Children's Hospital Ethics committee
Address 1-6-7, Minato-Jima Minami-Machi, Kobe-shi Chuo-Ku, Hyogo, Japan
Tel +81-78-945-7300
Email kodomo_hos@pref.hyogo.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
2020 Year 01 Month 22 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 29 Day
Date of IRB
2019 Year 11 Month 29 Day
Anticipated trial start date
2020 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 21 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044703

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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