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

October 7, 2010 updated by: Chongqing Medical University

A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

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) .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: methylprednisolone
methylprednisolone pulse azithromycin
Drug: methylprednisolone
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
Other Names:
  • treatment group
No Intervention: azithromycin
Drug: azithromycin
control patients were iv azithromycin for 5 days.
Other Names:
  • control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
3-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 .
3-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

October 6, 2010

First Submitted That Met QC Criteria

October 7, 2010

First Posted (Estimate)

October 8, 2010

Study Record Updates

Last Update Posted (Estimate)

October 8, 2010

Last Update Submitted That Met QC Criteria

October 7, 2010

Last Verified

May 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChiCTR-TRC2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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