Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Information source: Chongqing Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Refractory Mycoplasma Pneumoniae Pneumonia
Intervention: methylprednisolone (Drug); azithromycin (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Chongqing Medical University Official(s) and/or principal investigator(s): zhengxiu luo, doctor, Principal Investigator, Affiliation: Chongqing Medical University
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) .
Clinical Details
Official title: A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
Secondary outcome: safety of methylprednisolone pulse macrolide therapy for children with refractory 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
Eligibility
Minimum age: 3 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Additional Information
Starting date: May 2007
Last updated: October 7, 2010
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