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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
Chongqing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Mycoplasma Pneumoniae Pneumonia focused on measuring refractory mycoplasma pneumoniae pneumonia

Eligibility Criteria

3 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 6, 2010
    Last Updated
    October 7, 2010
    Sponsor
    Chongqing Medical University
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    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

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