Status:
COMPLETED
Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)
Lead Sponsor:
Beijing Children's Hospital
Collaborating Sponsors:
Shengjing Hospital
Children's Hospital of The Capital Institute of Pediatrics
Conditions:
Mycoplasma Pneumoniae Pneumonia
Eligibility:
All Genders
29-17 years
Phase:
NA
Brief 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 wi...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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:
- Less than 18 years old
- 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%
- 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
- 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.
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT02303587
Start Date
December 1 2014
End Date
October 16 2019
Last Update
January 8 2021
Active Locations (1)
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1
Beijing Children's Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100045