UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039210 |
|---|---|
| Receipt number | 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 | 2025/05/16 12:56:25 |
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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
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
shogo.ohtake@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Kobe Children's Hospital
Institute
Department
Personal name
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
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
Terminated
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
| 2025 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044703
