Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)
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|ClinicalTrials.gov Identifier: NCT02303587|
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : January 8, 2021
|Condition or disease||Intervention/treatment||Phase|
|Mycoplasma Pneumoniae Pneumonia||Drug: methylprednisolone||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||424 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial|
|Study Start Date :||December 2014|
|Actual Primary Completion Date :||October 16, 2019|
|Actual Study Completion Date :||October 16, 2019|
Experimental: low dose group
Experimental: high dose group
- pulmonary lesions [ Time Frame: 6 months ]Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation
- recovery time of temperature [ Time Frame: 2 weeks ]
- the proportion of absorption of pulmonary lesions [ Time Frame: 2 weeks ]
- duration of hospitalization, [ Time Frame: 2 weeks ]
- number of participant(s ) need intensive care [ Time Frame: 2 weeks ]
- number of participant(s )with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
- number of participant(s) with hemophagocytic syndrome [ Time Frame: 2 weeks ]
- number of participant(s) with hyperglycemia [ Time Frame: 2 weeks ]
- number of participant(s) with hypertension [ Time Frame: 6 months ]
- number of participant(s) who died during the trial [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303587
|Beijing Children's Hospital, Capital Medical University|
|Beijing, Beijing, China, 100045|
|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|