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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035994
Receipt No. R000040283
Scientific Title Efficacy of multiplex PCR among children with respiratory infection
Date of disclosure of the study information 2019/03/01
Last modified on 2019/03/16

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Basic information
Public title Efficacy of multiplex PCR among children with respiratory infection
Acronym Efficacy of multiplex PCR among children with respiratory infection
Scientific Title Efficacy of multiplex PCR among children with respiratory infection
Scientific Title:Acronym Efficacy of multiplex PCR among children with respiratory infection
Region
Japan

Condition
Condition Respiratory infection
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify safety, efficacy, reduction in antibiotics use, and cost effectiveness of multiplex PCR among children with respiratory infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Duration of antibiotics administration within 14 days of admission.
Key secondary outcomes Duration of mechanical ventilation, length of intensive care unit and hospital stay, mortality, complications due to antibiotics, and infectious complications within 28 days of admission. Proportion of broad antibiotics use, and cost of antibiotics within 14 days of admission.

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 We recommend not to use antibiotics when all the followings are satisfied: 1) viral pathogen is proved by multiplex PCR, 2) patient is respiratory and circulatory stable, and 3) white blood cell count <13.0x103/mm3 and CRP <5.0mg/dL. However, initiation or selection of antibiotics are decided according to physicians' judgement.
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
1 months-old <=
Age-upper limit
216 months-old >=
Gender Male and Female
Key inclusion criteria We include patients admit to the PICU or high care unit with diagnosis of respiratory infection according to respiratory symptoms, hypoxia, or radiograph, and who required oxygen.
Key exclusion criteria We exclude patients with immunodeficiency or who received therapeutic interventions for infections within the previous 1 month.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Hatachi
Organization Osaka Women's and Children's Hospital
Division name Department of Intensive Care Medicine
Zip code
Address Murodo-cho 840, Izumi-City, Osaka 594-1101, Japan
TEL 0725-56-1220
Email hatachi@mch.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Hatachi
Organization Osaka Women's and Children's Hospital
Division name Department of Intensive Care Medicine
Zip code
Address Murodo-cho 840, Izumi-City, Osaka 594-1101, Japan
TEL 0725-56-1220
Homepage URL
Email hatachi@mch.pref.osaka.jp

Sponsor
Institute Osaka Women's and Children's Hospital
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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
2019 Year 03 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
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 02 Month 24 Day
Date of IRB
2018 Year 11 Month 29 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 24 Day
Last modified on
2019 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040283

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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