Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Study Overview
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Brief Summary
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The purpose of this study is planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .

Detailed Description
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Corticosteroid has been used in adulthood refractory MPP with satisfactory efficacy. But there were few studies about the use of corticosteroid in children with refractory MPP. Lee KY et al indicated oral prednisolone of 1 mg/kg/ day for 1 week be useful for children with severe MPP. Akihiro T et al demonstrated that intravenously administered methylprednisolone at a dose of 30 mg/kg once daily for 3 consecutive days had an efficacious treatment for children with refractory MPP.But the methods of corticosteroid use, such as the dosage, administration route, duration of treatment have not been well understood. So in this study, we planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia in a prospective, open-label fashion. PMID: 11096025 PMID: 18033831 PMID: 10434547 PMID: 16437541 PMID: 18656264

Official Title
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A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Conditions
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Refractory Mycoplasma Pneumoniae Pneumonia

Intervention / Treatment
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* Drug: methylprednisolone
* Drug: azithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: mycoplasma pneumoniae pneumonia prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more. Exclusion Criteria: chronic cardiac and pulmonary disease immunodeficiency requiring mechanical ventilation with other pathogens detected during pneumonia.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 11 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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: methylprednisolone<br>methylprednisolone pulse azithromycin | Drug: methylprednisolone<br>* treatment patients were iv methylprednisolone pulse azithromycin for 5 days.<br>* Other names: treatment group;|
| No Intervention: azithromycin<br>azithromycin | Drug: azithromycin<br>* control patients were iv azithromycin for 5 days.<br>* Other names: control group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP. | compare the temperature , infiltration absorption,atelectasis resolution, pleural effusion disappearance,serum levels of ferritin and LDH between methylprednisolone pulse macrolide therapy group and macrolide therapy group . | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of methylprednisolone pulse macrolide therapy for children with refractory MPP. | observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group . | 3-year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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refractory mycoplasma pneumoniae pneumonia