Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children (MPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01217099
Recruitment Status : Terminated (terminated)
First Posted : October 8, 2010
Last Update Posted : October 8, 2010
Sponsor:
Information provided by:
Chongqing Medical University

Tracking Information
First Submitted Date  ICMJE October 6, 2010
First Posted Date  ICMJE October 8, 2010
Last Update Posted Date October 8, 2010
Study Start Date  ICMJE May 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ]
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 .
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2010)
safety of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ]
observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
Official Title  ICMJE A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Refractory Mycoplasma Pneumoniae Pneumonia
Intervention  ICMJE
  • Drug: methylprednisolone
    treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
    Other Name: treatment group
  • Drug: azithromycin
    control patients were iv azithromycin for 5 days.
    Other Name: control group
Study Arms  ICMJE
  • No Intervention: methylprednisolone
    methylprednisolone pulse azithromycin
    Intervention: Drug: methylprednisolone
  • No Intervention: azithromycin
    azithromycin
    Intervention: Drug: azithromycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 7, 2010)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01217099
Other Study ID Numbers  ICMJE ChiCTR-TRC2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party zhengxiu luo, Children's Hospital of Chongqing Medical University
Study Sponsor  ICMJE Chongqing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: zhengxiu luo, doctor Chongqing Medical University
PRS Account Chongqing Medical University
Verification Date May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP