Dataset Information

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.

Project description:BackgroundIt is unclear whether local pathological pulmonary changes truly reflect the severity of childhood Mycoplasma pneumoniae infection, which is characterized by rapid progress and potential mortality. This study multi-dimensionally analyzed low-dose computed tomography findings to assess the severity of Mycoplasma pneumoniae infection and predict its progress in such patients.MethodsIn all, 752 children with Mycoplasma pneumoniae pneumonia (MPP) who underwent low-dose computed tomography examinations from February 2016 to July 2020 were retrospectively enrolled to conduct a cohort study. Clinical and radiological variables were analyzed using univariate analysis, and radiological variables were further analyzed using multivariable logistic regression in severe cases. Then, the correlation between the key computed tomography features and clinical symptoms, laboratory indicators, and medical costs were assessed using the chi-squared and Kruskal-Wallis H tests. Kaplan-Meier curves and Cox regression models were created to evaluate the correlations between the key computed tomography features, fever duration, and the length of hospital stay.ResultsOf the 752 included patients, 16.2% (122/752) developed severe MPP. Atelectasis, pleural effusion, and lung consolidation occurred in 9.7% (73/752), 15.8% (119/752), and 90.3% (679/752) of patients, respectively. In addition to pleural effusion, the number of lobes of lung consolidation was the highest risk feature of severe MPP. Patients with consolidation in 2, 3, and 4 lobes had a 1.0-, 3.1-, and 7.5-fold increased risk of severe MPP, compared with patients with consolidation in fewer than 1 lobe. The duration of fever prior to admission had no effect on the proportions of the lobar consolidation (P=0.14) but did have significant effect on the incidence of pleural effusion (P=0.004). Levels of inflammatory markers and medical costs rose consistently with the increase in the number of lobar consolidations (P<0.001). After adjustments for pleural effusion, 1, 2, 3, and 4 lobes of consolidation remained positively associated with fever duration [1 lobe: hazard ratio (HR) =1.55, 95% CI: 1.10-2.18; 2 lobes: HR =1.65, 95% CI: 1.13-2.42l; 3 lobes: HR =1.82, 95% CI: 1.11-2.98; 4 lobes: HR =2.87, 95% CI: 1.25-6.61] compared to 0 lobes of consolidation. Compared to 0 lobes of consolidation, 1, 2, 3, and 4 lobes of consolidation were also positively correlated with the length of hospital stay (1 lobe: HR =2.24, 95% CI: 1.73-2.89; 2 lobes: HR =2.56, 95% CI: 1.91-3.43; 3 lobes: HR =2.87, 95% CI: 1.90-4.32; 4 lobes: HR =4.12, 95% CI: 2.01-8.46).ConclusionsLobar consolidation is a stable and reliable computed tomography feature that can be used to assess the severity of MPP in children. Quantitative analysis of lobar consolidation can comprehensively and accurately predict the progression of Mycoplasma pneumoniae. Low-dose computed tomography is recommended for children with severe MPP with complicated courses.

Project description:BackgroundMycoplasma pneumoniae (M. pneumoniae) is an important pathogen of community-acquired pneumonia in children. The factors contributing to the severity of illness caused by M. pneumoniae infection are still under investigation. We aimed to evaluate the sensitivity of common M. pneumoniae detection methods, as well as to analyze the clinical manifestations, genotypes, macrolide resistance, respiratory microenvironment, and their relationship with the severity of illness in children with M. pneumoniae pneumonia in Wuhan.ResultsAmong 1,259 clinical samples, 461 samples were positive for M. pneumoniae via quantitative polymerase chain reaction (qPCR). Furthermore, we found that while serological testing is not highly sensitive in detecting M. pneumoniae infection, but it may serve as an indicator for predicting severe cases. We successfully identified the adhesin P1 (P1) genotypes of 127 samples based on metagenomic and Sanger sequencing, with P1-type 1 (113/127, 88.98%) being the dominant genotype. No significant difference in pathogenicity was observed among different genotypes. The macrolide resistance rate of M. pneumoniae isolates was 96% (48/50) and all mutations were A2063G in domain V of 23S rRNA gene. There was no significant difference between the upper respiratory microbiome of patients with mild and severe symptoms.ConclusionsDuring the period of this study, the main circulating M. pneumoniae was P1-type 1, with a resistance rate of 96%. Key findings include the efficacy of qPCR in detecting M. pneumoniae, the potential of IgM titers exceeding 1:160 as indicators for illness severity, and the lack of a direct correlation between disease severity and genotypic characteristics or respiratory microenvironment. This study is the first to characterize the epidemic and genomic features of M. pneumoniae in Wuhan after the COVID-19 outbreak in 2020, which provides a scientific data basis for monitoring and infection prevention and control of M. pneumoniae in the post-pandemic 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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