Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

• Status: Completed
• Trial end date: 2019-10-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Children's Hospital
• Collaborators: Baoding Children's Hospital; Capital Institute of Pediatrics, China; Children's Hospital of Changchun; Children's Hospital of The Capital Institute of Pediatrics; Shanxi Provincial Maternity and Children's Hospital; Shengjing Hospital; Women and Children's Health Hospital of yinchuan City
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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%

3. 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.