Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.

Official Title
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Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children

Conditions
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Mycoplasma Pneumoniae Pneumonia

Intervention / Treatment
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* Drug: Prednisolone
* Drug: Levofloxacin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Evidence of Mycoplasma pneumoniae infection Lobar pneumonia or pneumoniae with pleural effusion Exclusion Criteria: Immunosuppresant host Chronic cardiovascular/pulmonary disease Hospital acquired infection

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steroid<br>Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days | Drug: Prednisolone<br>* PO prednisolone, 1 mg/kg/day, for 5 days<br>* Other names: Solondo;Drug: Levofloxacin<br>* Levofloxacin, 10mg/kg/day, IV, for 5days<br>|
| Active Comparator: Control<br>Levofloxacin, 10mg/kg/day, IV, for 5days | Drug: Levofloxacin<br>* Levofloxacin, 10mg/kg/day, IV, for 5days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever duration |  | within the first 14 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |