Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Not Applicable

Terminated

• Conditions: Refractory Mycoplasma Pneumoniae Pneumonia
• Interventions: Drug: methylprednisolone; Drug: azithromycin

• Registration Number: NCT01217099
• Lead Sponsor: Chongqing Medical University

Brief Summary

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

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

Study Timeline

• Status Verified: 2007-05
• Study Start: 2007-05
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Study First Submitted: 2010-10-06
• Study First Submitted QC: 2010-10-07
• Last Update Submitted: 2010-10-07
• Study First Posted: 2010-10-08
• Last Update Posted: 2010-10-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone	methylprednisolone	methylprednisolone pulse azithromycin
azithromycin	azithromycin	azithromycin

Primary Outcome Measures

Name	Time	Method
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.	3-year	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 .

Secondary Outcome Measures

Name	Time	Method
safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.	3-year	observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .