Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children (MPP)
Refractory Mycoplasma Pneumoniae Pneumonia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children|
- efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ] [ Designated as safety issue: No ]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 .
- safety of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .
|Study Start Date:||May 2007|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
No Intervention: methylprednisolone
methylprednisolone pulse azithromycin
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
Other Name: treatment group
No Intervention: azithromycin
control patients were iv azithromycin for 5 days.
Other Name: control group
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01217099
|Principal Investigator:||zhengxiu luo, doctor||Chongqing Medical University|