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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031674
Receipt No. R000036179
Scientific Title A prospective multicenter randomized controlled trial for the effect of high-dose corticosteroid on refractory Mycoplasma Pneumoniae pneumonia in children
Date of disclosure of the study information 2018/10/01
Last modified on 2018/03/12

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Basic information
Public title A prospective multicenter randomized controlled trial for the effect of high-dose corticosteroid on refractory Mycoplasma Pneumoniae pneumonia in children
Acronym Effect of corticosteroid on Mycoplasma Pneumoniae pneumonia
Scientific Title A prospective multicenter randomized controlled trial for the effect of high-dose corticosteroid on refractory Mycoplasma Pneumoniae pneumonia in children
Scientific Title:Acronym Effect of corticosteroid on Mycoplasma Pneumoniae pneumonia
Region
Japan

Condition
Condition Mycoplasma Pneumoniae pneumonia
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of high-dose corticosteroid on refractory Mycoplasma Pneumoniae pneumonia in children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The duration of fever from the start of steroid therapy
Key secondary outcomes Relapse of fever, the duration of hospitalization, reduction rate of LDH and CRP

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Low dose cohot
Initial dose of prednisolone 1mg/kg/day
Interventions/Control_2 High dose cohot
Initial dose of prednisolone 2mg/kg/day
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 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria Pediatric patients with Mycoplasma Pneumoniae pneumonia who are refractory to at least 2 types of antibiotics.
Key exclusion criteria Patients
1.who need intubation by respiratory failure
2.who do not receive enough antibiotics therapy(at least by 2 groups of antibiotics ;Macrolid, Newquinolone or tetracycline)
3.who receive steroid therapy except for refractory Mycoplasma Pneumoniae pneumonia (such as asthma)
who diagnosed as other diseases, such as HPS or Kawasaki Disease.
4.with Congenital heart diseases, metabolic disorder, neurologic dis order, bronchopulmonary disorder, or immune deficiency
5.who have allery of steroid
6.who is negative in immune-serological verification
Target sample size 46

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Takahashi
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics / Developmental Pediatrics
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan 466-8550
TEL +81-52-741-2111
Email ytakaha@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junichi Kawada
Organization Nagoya University Graduate School of Medicine
Division name Department of Pediatrics / Developmental Pediatrics
Zip code
Address 65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan 466-8550
TEL +81-52-741-2111
Homepage URL
Email kawadaj@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine, Department of Pediatrics / Developmental Pediatrics
Institute
Department

Funding Source
Organization Nagoya University
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
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
2018 Year 10 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 01 Day
Last follow-up date
2023 Year 07 Month 31 Day
Date of closure to data entry
2023 Year 09 Month 30 Day
Date trial data considered complete
2023 Year 10 Month 31 Day
Date analysis concluded
2024 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 12 Day
Last modified on
2018 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036179

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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