UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044479 |
|---|---|
| Receipt number | R000050785 |
| Scientific Title | Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial |
| Date of disclosure of the study information | 2021/06/09 |
| Last modified on | 2023/10/26 12:09:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial
Acronym
Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial
Scientific Title
Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial
Scientific Title:Acronym
Study of evaluating shortening of a fever period after steroid therapy for Mycoplasma Pneumoniae:non-blind randomized controlled trial
Region
| Japan |
Condition
Condition
Mycoplasma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of steroid therapy to shortening of fever period in children with Mycoplasm pneumoniae
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from case registration to fever reduction
Key secondary outcomes
1)Time to meet all discharge criteria
The discharge criteria are defined as the following three items.
a)Less than 37.5 degrees lasts for 12 hours or more
b)Does not require continuous infusion
c)More than 12 hours have passed since the increasing oxygen demand disappeared.
2)Percentage of subjects with fever (37.5 degrees or higher) on the 3rd day of registration
3)Percentage of subjects who meet the discharge criteria on the 7th day of registration
4)Subpopulation analysis of the following items (LDH is more than 480 U/L presence / absence, oxygen administration presence / absence at the time of registration, severity classification)
Fever period
Time to meet discharge criteria
Oxygen administration period
5)Percentage of subjects who required positive pressure management or intensive care management
6)Percentage of adverse events
7)Percentage of relapsed patients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Antibiotics + Prednisolone 0.5 mg/kg/dose(three times daily for 5 days)
Interventions/Control_2
Antibiotics
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
| 18 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Men and women under the age of 18
2) Mycoplasma positive by nucleic acid amplification test or immunochromatography
3) Those who had pneumonia on chest X-ray or chest CT, had respiratory symptoms, were diagnosed with acute pneumonia, and were hospitalized.
4) Axillary body temperature of 38 degrees or higher at admission
5) Those who have received sufficient explanation for participating in this study, and have obtained the voluntary consent of the person or his / her substitute after sufficient understanding.
Key exclusion criteria
1) Intravenous or oral steroids were given after a series of symptoms that caused hospitalization were observed (regardless of the use of topical steroids and inhaled steroids).
2) Those with the following pre-existing conditions
Bronchial asthma, immunodeficiency, congenital respiratory disease, congenital disease with abnormal hemodynamics, premature birth / low birth weight infant, post-tracheostomy, gastroesophageal reflux disease, severely handicapped child
3) Those judged to require positive pressure ventilation or intensive care management
4) Those who cannot start treatment within 24 hours after admission
5) Others that the principal investigator deems inappropriate as a research subject
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Matsushima |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
General Pediatrics
Zip code
183-8561
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-300-5111
takahiro_matsushima@tmhp.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Matsushima |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
General Pediatrics
Zip code
183-8561
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-300-51111
Homepage URL
takahiro_matsushima@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
Tel
042-300-5111
takahiro_matsushima@tmhp.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
| 2021 | Year | 06 | Month | 09 | 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
| 2020 | Year | 12 | Month | 23 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 06 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050785
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
