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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044479
Receipt No. 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 2021/06/09

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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 Takashi
Middle name
Last name Esaki
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Pediatrics
Zip code 170-8476
Address 2-8-1 Minamiohtsuka Toshima-ku Tokyo
TEL 03-3941-3211
Email takashi_esaki@tmhp.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Esaki
Organization Tokyo Metropolitan Ohtsuka Hospital
Division name Pediatrics
Zip code 170-8476
Address 2-8-1 Minamiohtsuka Toshima-ku Tokyo
TEL 03-3941-3211
Homepage URL
Email takashi_esaki@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Ohtsuka Hospital
Institute
Department

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 Ohtsuka Hospital
Address 2-8-1 Minamiohtsuka Toshima-ku Tokyo
Tel 03-3941-3211
Email takashi_esaki@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
2024 Year 12 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
2021 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.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


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