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Low-dose versus high-dose methylprednisolone for children with severe Mycoplasma pneumoniae pneumonia (MCMP): Study protocol for a randomized controlled trial.

ABSTRACT: Background:Severe Mycoplasma 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 severe M. 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).

SUBMITTER: Xu B

PROVIDER: S-EPMC7331410 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Low-dose versus high-dose methylprednisolone for children with severe <i>Mycoplasma pneumoniae</i> pneumonia (MCMP): Study protocol for a randomized controlled trial.

Xu Baoping B Peng Xiaoxia X Yao Yao Y Yin Ju J Chen Lanqin L Liu Jun J Wang Hao H Gao Liwei L Shen Adong A Shen Kunling K

Pediatric investigation 20180901 3

<h4>Background</h4>Severe <i>Mycoplasma pneumoniae</i> 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.<h4>Methods</h4>A randomized, single-blind, parallel-controlle ...[more]

PMID: 32851257

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Project description:Background: The clinical value of corticosteroid treatment in Mycoplasma pneumoniae pneumonia (MPP) has been controversial. Our study aimed to identify the effects of low-dose corticosteroids on the recovery of children with MPP. Methods: In this retrospective cohort study, pediatric inpatients with MPP were included from the Shanghai Children's Mycoplasma pneumoniae pneumonia cohort study between August 2014 and July 2019. The multivariable logistic regression and propensity-score matching were used to investigate the effects of low-dose corticosteroid treatment on fever duration after admission, total fever duration, length of hospital stay, C-reactive protein recovery time, and imaging recovery time with the stratification of severe pneumonia, refractory pneumonia, inflammatory biomarkers, pulmonary images, and timing of corticosteroids. Results: There were 548 patients in the corticosteroid group and 337 in the no-corticosteroid group. The corticosteroid group showed severe clinical parameters such as more severe and refractory cases, higher laboratory values, and more abnormal imaging manifestations. The corticosteroid group also showed longer fever duration after admission [odds ratio (OR) = 1.9 (95% CI, 1.2-3.1), P = 0.008], longer total fever duration [OR = 1.6 (95% CI, 1.1-2.3), P = 0.011], longer hospital stay [OR = 2.8 (95% CI, 1.9-4.0), P < 0.001], and longer C-reactive protein (CRP) recovery time [OR = 2.1 (95% CI, 1.1-3.9), P = 0.021] in the regression model after the adjustment for severity. Although low-dose corticosteroids were associated with shortened imaging recovery time in patients with high level laboratory values, pulmonary imaging could be completely recovered in both groups. The trend of these results was consistent even after stratifications and a propensity scores matching analysis. Conclusions: Low-dose corticosteroids may not be beneficial in children inpatients with MPP, and further studies on proper treatment modality are needed in the MRMP era.

Dataset Information

Low-dose versus high-dose methylprednisolone for children with severe Mycoplasma pneumoniae pneumonia (MCMP): Study protocol for a randomized controlled trial.

Publications

Low-dose versus high-dose methylprednisolone for children with severe <i>Mycoplasma pneumoniae</i> pneumonia (MCMP): Study protocol for a randomized controlled trial.

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