Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

January 6, 2021 updated by: Baoping XU, Beijing Children's Hospital

Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial

The study is designed to investigate difference in percentage of presentation of atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after discharge in those treated with a low dose regimen of methylprednisolone initiated with 2 or 4 mg/kg/d for 3 days followed by tapering, combined with sequential treatment with azithromycin versus a high dose regimen of methylprednisolone initiated with 10 mg/kg/d for 3 days followed by tapering, combined with sequential treatment with azithromycin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mycoplasma pneumonia pneumonia (MPP) accounts for approximately 10-30% of childhood community-acquired pneumonia (CAP) in China. Macrolide is the first choice for MPP. However, progression to severe pneumonia might occur despite antibiotics therapy. And some patients have sequelae of bronchiolitis obliterans, bronchiectasis and atelectasis, et al. Based on inflammatory and immunological mechanism, there is some clinical evidence that adjuvant of corticosteroid reduced morbidity and improved the outcome in the children with severe MPP. However, the dosage of corticosteroid varied greatly in studies. Therefore, a large prospective study is needed to define the benefits of high-dose corticosteroid therapy in MPP.

Patients will be randomized into two groups: the low dose group and the high dose group. The low dose group will receive methylprednisolone 2 or 4 mg/kg/d for 3 days followed by tapering in 9 days, combined with sequential treatment with azithromycin. The high dose group will receive methylprednisolone 10 mg/kg/d for 3 days followed by tapering in 9 days, combined with sequential treatment with azithromycin. After discharge, patients of both groups will be followed up at 1, 3, and 6 months.

The number of pulmonary lesions, including atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidations, in 6 months after discharge will be compared in two groups. The number of adverse events, such as hyperglycemia, hypertension, increased intraocular pressure, will be compared between the two groups.

The trial will be completed in 36 months, with 424 subjects recruited from 5 hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.

Study Type

Interventional

Enrollment (Actual)

424

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100045
        • Beijing Children's Hospital, Capital Medical University

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

4 weeks to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Severe pneumonia diagnosis criteria were based on the "Zhu Futang Practical Pediatrics" (the 7th Edition) and "the guideline of management of community-acquired pneumonia in children in China"(Chinese Journal of Pediatrics, 2013, 51:745-752, 856-862). Severe pneumonia is defined as pneumonia with one of the following:

  1. Less than 18 years old

  2. Severe pneumonia that is defined as pneumonia with one of the followings:

    • poor general condition
    • increased respiratory rate( infant>70/min，older children>50/min)
    • dyspnea
    • cyanosis
    • multilobe involvement or ≥ 2/3 lung involvement
    • extrapulmonary complication
    • pleural effusion
    • Transcutaneous oxygen saturation in room air ≤92%
  3. Serum M. pneumoniae antibody≥ 1:320, or serum M. pneumoniae antibody≥ 1:160 with positive PCR of M. pneumoniae or seroconversion (increased antibody titers ≥4 folds) Subject/Guardian is informed and consent.

Exclusion Criteria:

Subject will be excluded if she or he has one of the following:

  • evidence of bacterial pneumonia;
  • evidence of viral pneumonia;
  • evidence of fugal pneumonia;
  • evidence of pulmonary tuberculosis;
  • respiratory failure requiring mechanical ventilation;
  • hemophagocytic syndrome;
  • liver failure or renal insufficiency;
  • congenital heart disease;
  • heart failure;
  • kidney disease;
  • connective tissue disease;
  • immunodeficiency;
  • tumor;
  • a history of hypertension or diabetes mellitus;
  • recurrent respiratory tract infection;
  • congenital bronchopulmonary dysplasia;
  • increased intraocular pressure;
  • history of use of glucocorticoids ≥1 week in previous 3 months;
  • having contraindications to glucocorticoids or azithromycin;
  • using of immunosuppressant before randomization;
  • undergoing trial for other medications or instruments.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: low dose group
methylprednisolone 2mg-4mg/Kg
Drug: methylprednisolone
Experimental: high dose group
methylprednisolone 10mg/Kg
Drug: methylprednisolone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pulmonary lesions
Time Frame: 6 months
Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
recovery time of temperature
Time Frame: 2 weeks
2 weeks
the proportion of absorption of pulmonary lesions
Time Frame: 2 weeks
2 weeks
duration of hospitalization,
Time Frame: 2 weeks
2 weeks
number of participant(s ) need intensive care
Time Frame: 2 weeks
2 weeks
number of participant(s )with acute respiratory distress syndrome
Time Frame: 2 weeks
2 weeks
number of participant(s) with hemophagocytic syndrome
Time Frame: 2 weeks
2 weeks
number of participant(s) with hyperglycemia
Time Frame: 2 weeks
2 weeks
number of participant(s) with hypertension
Time Frame: 6 months
6 months
number of participant(s) who died during the trial
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Beijing Children's Hospital

Collaborators

Shengjing Hospital
Shanxi Provincial Maternity and Children's Hospital
Baoding Children's Hospital
Children's Hospital of The Capital Institute of Pediatrics

Investigators

  • Principal Investigator: Baoping Xu, MD, PhD, Beijing Children's Hospital of Capital Medical University, China
  • Principal Investigator: Xiaoxia Peng, MD, PhD, Beijing Children's Hospital of Capital Medical University, China

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.

General Publications

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

December 1, 2014

Primary Completion (Actual)

October 16, 2019

Study Completion (Actual)

October 16, 2019

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

December 1, 2014

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 6, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCHlung001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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