Low-dose versus high-dose methylprednisolone for children with severepneumonia (MCMP): Study protocol for a randomized controlled trial

Background: SevereMycoplasma pneumoniae pneumonia (MPP) may develop with long-term pulmonary outcomes despite treatment with macrolides. Combined treatment with glucocorticoids can improve this outcome, though the optimal dosage is unknown. The aim of this study was to investigate the effects of low- and high-dose methylprednisolone in reducing the percentage of long-term pulmonary outcomes for children with severe MPP.Methods: A randomized, single-blind, parallel-controlled, multicenter clinical trial, methylprednisolone for children with severeM. pneumoniae pneumonia (MCMP), is being conducted in China. Pediatric patients (≤18 years of age, expected number = 402) admitted to the hospital with a clinical diagnosis of severe MPP and fulfilling inclusion and exclusion criteria are randomized (ratio of 1:1) to either a low-dose (2 mg/kg/d) or high-dose (10 mg/kg/d) methylprednisolone treatment group for 3 days followed by tapering of methylprednisolone over 12 days and combined with azithromycin. The primary composite outcome will be incidence of atelectasis, bronchiectasis, or bronchiolitis obliterans at 6-months after treatment. Secondary outcomes include recovery time of patient temperature, proportion of pulmonary lesions absorbed, changes of mucosa identified by bronchoscopy, length of hospital stay, pulmonary function and number of participant(s) needing intensive care. Assessments will be made at baseline, post-treatment and at 1-month, 3-month and 6-month follow-ups.Discussion: This is the first randomized clinical trial designed to evaluate the safety and efficacy of low- versus high-dose methylprednisolone for reducing long-term pulmonary outcomes in pediatric patients with severe MPP. The results of this study will provide scientific evidence to guide clinical practice for the treatment of severe MPP.Trial registration: This study is registered at ClinicalTrials.gov (NCT02303587).