Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children (MPP)
Primary Purpose
Refractory Mycoplasma Pneumoniae Pneumonia
Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
methylprednisolone
azithromycin
Sponsored by
About this trial
This is an interventional treatment trial for Refractory Mycoplasma Pneumoniae Pneumonia focused on measuring refractory mycoplasma pneumoniae pneumonia
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
No Intervention
Arm Label
methylprednisolone
azithromycin
Arm Description
methylprednisolone pulse azithromycin
azithromycin
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
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 .
Full Information
NCT ID
NCT01217099
First Posted
October 6, 2010
Last Updated
October 7, 2010
Sponsor
Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01217099
Brief Title
Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Acronym
MPP
Official Title
A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Terminated
Why Stopped
terminated
Study Start Date
May 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Mycoplasma Pneumoniae Pneumonia
Keywords
refractory mycoplasma pneumoniae pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
methylprednisolone
Arm Type
No Intervention
Arm Description
methylprednisolone pulse azithromycin
Arm Title
azithromycin
Arm Type
No Intervention
Arm Description
azithromycin
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Other Intervention Name(s)
treatment group
Intervention Description
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
Intervention Type
Drug
Intervention Name(s)
azithromycin
Other Intervention Name(s)
control group
Intervention Description
control patients were iv azithromycin for 5 days.
Primary Outcome Measure Information:
Title
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
Description
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 .
Time Frame
3-year
Secondary Outcome Measure Information:
Title
safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.
Description
observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .
Time Frame
3-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhengxiu luo, doctor
Organizational Affiliation
Chongqing Medical University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
http://www.clinicaltrials.gov
Description
Related Info
Learn more about this trial
Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
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