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Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

Sponsor
Beijing Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02303587
Collaborator
Shengjing Hospital (Other), Children's Hospital of The Capital Institute of Pediatrics (Other), Shanxi Provincial Maternity and Children's Hospital (Other), Baoding Children's Hospital (Other)
424
Enrollment
1
Location
2
Arms
58.5
Duration (Months)
7.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
424 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Oct 16, 2019
Actual Study Completion Date :
Oct 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: low dose group

methylprednisolone 2mg-4mg/Kg

Drug: methylprednisolone
Experimental: high dose group

methylprednisolone 10mg/Kg

Drug: methylprednisolone

Outcome Measures

Primary Outcome Measures

  1. pulmonary lesions [6 months]

    Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation

Secondary Outcome Measures

  1. recovery time of temperature [2 weeks]

  2. the proportion of absorption of pulmonary lesions [2 weeks]

  3. duration of hospitalization, [2 weeks]

  4. number of participant(s ) need intensive care [2 weeks]

  5. number of participant(s )with acute respiratory distress syndrome [2 weeks]

  6. number of participant(s) with hemophagocytic syndrome [2 weeks]

  7. number of participant(s) with hyperglycemia [2 weeks]

  8. number of participant(s) with hypertension [6 months]

  9. number of participant(s) who died during the trial [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
29 Days to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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%

  1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Children's Hospital, Capital Medical University Beijing Beijing China 100045

Sponsors and Collaborators

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

Investigators

  • Study Director: Kunling Shen, MD,PhD, Beijing Children's Hospital of Capital Medical University, China
  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Baoping XU, Chief of Respiratory Department, Beijing Children's Hospital
ClinicalTrials.gov Identifier:
NCT02303587
Other Study ID Numbers:
  • BCHlung001
First Posted:
Dec 1, 2014
Last Update Posted:
Jan 8, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Baoping XU, Chief of Respiratory Department, Beijing Children's Hospital
Severe mycoplasma pneumoniae
pneumonia
children
Additional relevant MeSH terms:
Pneumonia
Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate

Study Results

No Results Posted as of Jan 8, 2021