UMIN-CTR Clinical Trial

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

central nervous system infection, encephalitis, meningitis

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Duration of use of acyclovir for subjects

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo Prefectural Kobe Children's Hospital

Institute

Department

Personal name

Organization

Japanese Society for Pediatric Infectious Diseases

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

01

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

01

Month

21

Day

Last modified on

2020

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044703