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Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

Primary Purpose

Mycoplasma Pneumoniae Pneumonia

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

methylprednisolone

About this trial

This is an interventional treatment trial for Mycoplasma Pneumoniae Pneumonia focused on measuring Severe mycoplasma pneumoniae, pneumonia, children

Eligibility Criteria

29 Days - 17 Years (Child)All SexesDoes not accept healthy volunteers

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:

Less than 18 years old
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%
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.

Sites / Locations

Beijing Children's Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

low dose group

high dose group

Arm Description

methylprednisolone 2mg-4mg/Kg

methylprednisolone 10mg/Kg

Outcomes

Primary Outcome Measures

pulmonary lesions

Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation

Secondary Outcome Measures

recovery time of temperature

the proportion of absorption of pulmonary lesions

duration of hospitalization,

number of participant(s ) need intensive care

number of participant(s )with acute respiratory distress syndrome

number of participant(s) with hemophagocytic syndrome

number of participant(s) with hyperglycemia

number of participant(s) with hypertension

number of participant(s) who died during the trial

Full Information

NCT ID

NCT02303587

First Posted

November 21, 2014

Last Updated

January 6, 2021

Sponsor

Beijing Children's Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02303587

Brief Title

Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

October 16, 2019 (Actual)

Study Completion Date

October 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Children's Hospital

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mycoplasma Pneumoniae Pneumonia

Keywords

Severe mycoplasma pneumoniae, pneumonia, children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low dose group

Arm Type

Experimental

Arm Description

methylprednisolone 2mg-4mg/Kg

Arm Title

high dose group

Arm Type

Experimental

Arm Description

methylprednisolone 10mg/Kg

Intervention Type

Drug

Intervention Name(s)

methylprednisolone

Primary Outcome Measure Information:

Title

pulmonary lesions

Description

Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation

Time Frame

6 months

Secondary Outcome Measure Information:

Title

recovery time of temperature

Time Frame

2 weeks

Title

the proportion of absorption of pulmonary lesions

Time Frame

2 weeks

Title

duration of hospitalization,

Time Frame

2 weeks

Title

number of participant(s ) need intensive care

Time Frame

2 weeks

Title

number of participant(s )with acute respiratory distress syndrome

Time Frame

2 weeks

Title

number of participant(s) with hemophagocytic syndrome

Time Frame

2 weeks

Title

number of participant(s) with hyperglycemia

Time Frame

2 weeks

Title

number of participant(s) with hypertension

Time Frame

6 months

Title

number of participant(s) who died during the trial

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

29 Days

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Less than 18 years old 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% 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kunling Shen, MD,PhD

Organizational Affiliation

Beijing Children's Hospital of Capital Medical University, China

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Baoping Xu, MD, PhD

Organizational Affiliation

Beijing Children's Hospital of Capital Medical University, China

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Xiaoxia Peng, MD, PhD

Organizational Affiliation

Beijing Children's Hospital of Capital Medical University, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beijing Children's Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100045

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

Chinese maternal and child health development report (2011). The Ministry of health of the people's Republic of China

Results Reference

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PubMed Identifier

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Citation

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Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

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