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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

Page last updated: August 23, 2015

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