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A multi center, randomized, single blind clinical trial to evaluate the efficacy and safety of low dose and high dose methylprednisolone in the treatment of severe pediatric mycoplasma pneumonia

A multi center, randomized, single blind clinical trial to evaluate the efficacy and safety of low dose and high dose methylprednisolone in the treatment of severe pediatric mycoplasma pneumonia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14004321
Enrollment
Unknown
Registered
2014-02-26
Start date
2014-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe Mycoplasma pneumoniae pneumonia in children

Interventions

Group 1:methylprednisolone 2mg/Kg
group 2:methylprednisolone 10mg/Kg

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 5 Years

Inclusion criteria

Inclusion criteria: Mycoplasma pneumoniae pneumonia diagnosis criteria were based on the "Zhu Futang Practical Pediatrics" (Seventh Edition): (1) have a fever>38.5 degree C; (2) increased respiratory rate(infant>70/minelder children>50/min); (3) dyspnea; (4) cyonosis; (5) Multi lobe involvement or = 2/3 lung involvement; (6) ultrapulmonary complication; (7) pleural effussion; (8) Transcutaneous oxygen saturation =92%; (9) Macrolide antibiotics in the treatment of 1 weeks is invalid. Subjects were informed and understand the adverse reactions.

Exclusion criteria

Exclusion criteria: 1. common sputum bacterial smear positive; 2. respiratory virus antigen positive; 3. hyphae and spores were found in smear; 4. acid fast staining was found in smear; 5. PPD (48h) positive; 6. respiratory failure, requiring mechanical ventilation; 7. hemophagocytic syndrome; 8. serious liver failure or renal insufficiency; 9. congenital heart disease; 10. heart failure; 11. kidney disease; 12. connective tissue disease; 13. immunodeficiency disease; 14. tumor; 15. a history of hypertension, history of diabetes mellitus; 16. recurrent respiratory tract infection; 17. Congenital Bronchopulmonary dysplasia; 18. abnormal liver function or blood sodium retention, osteoporosis; 19. history of long-term use of glucocorticoid; 20. allergy history; 21. there are contraindications to the use of corticosteroids, azithromycin; 22. use of immunosuppressant within 1 week; 23. undergoing testing drugs or instruments.

Design outcomes

Primary

MeasureTime frame
fever clearance time;The recovery rate of lung lesion;

Countries

China

Contacts

Public ContactXu Baoping

Beijing Children's Hospital, Capital Medical University

xubaoping@yahoo.com+86 13370115002

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026