Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
1 other identifier
interventional
80
1 country
1
Brief Summary
Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2016
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 27, 2018
April 1, 2018
4.5 years
November 8, 2015
April 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Fever duration
within the first 14 days after intervention
Secondary Outcomes (3)
Number of patients improved in chest X-ray
within the first 7 days after intervention
Number of patients with side effect of steroid
within the first 14 days after intervention
Number of patients improved in chest X-ray
within the first 14 days after intervention
Study Arms (2)
Steroid
EXPERIMENTALPrednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
Control
ACTIVE COMPARATORLevofloxacin, 10mg/kg/day, IV, for 5days
Interventions
Eligibility Criteria
You may qualify if:
- Evidence of Mycoplasma pneumoniae infection
- Lobar pneumonia or pneumoniae with pleural effusion
You may not qualify if:
- Immunosuppresant host
- Chronic cardiovascular/pulmonary disease
- Hospital acquired infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Children's Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eun Hwa Choi, M.D., Ph.D.
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2015
First Posted
December 1, 2015
Study Start
June 1, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
April 27, 2018
Record last verified: 2018-04