Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

NCT ID: NCT02303587

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2019-10-16

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.

Conditions

Mycoplasma Pneumoniae Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

low dose group

methylprednisolone 2mg-4mg/Kg

Group Type: EXPERIMENTAL

methylprednisolone

Intervention Type: DRUG

high dose group

methylprednisolone 10mg/Kg

Group Type: EXPERIMENTAL

methylprednisolone

Intervention Type: DRUG

Interventions

methylprednisolone

Intervention Type: DRUG

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:

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.

• Minimum Eligible Age: 29 Days
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Children's Hospital of The Capital Institute of Pediatrics

OTHER

Sponsor Role: collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role: collaborator

Baoding Children's Hospital

OTHER

Sponsor Role: collaborator

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Baoping XU

Chief of Respiratory Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kunling Shen, MD,PhD

Role: STUDY_DIRECTOR

Beijing Children's Hospital of Capital Medical University, China

Baoping Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital of Capital Medical University, China

Xiaoxia Peng, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beijing Children's Hospital of Capital Medical University, China

Locations

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

References

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

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

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Other Identifiers

BCHlung001

Identifier Type: -

Identifier Source: org_study_id