UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031674 |
|---|---|
| Receipt number | 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 | 2023/10/23 21:46:26 |
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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 | Yoshiyuki |
| Middle name | |
| Last name | Takahashi |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics / Developmental Pediatrics
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan 466-8550
TEL
+81-52-741-2111
ytakaha@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Kawada |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics / Developmental Pediatrics
Zip code
466-8550
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan 466-8550
TEL
+81-52-741-2111
Homepage URL
kawadaj@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Pediatrics / Developmental Pediatrics
Institute
Department
Personal name
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
IRB in Nagoya University Hospital
Address
65, Tsurumai-cho, Showa-ku, Nagoya city, Aichi, Japan 466-8550
Tel
+81-52-741-2111
ethics@med.nagoya-u.ac.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
| 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
| 2023 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036179
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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