Clinical Trial: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Brief Summary: Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.
Detailed Summary: Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.
Sponsor: Seoul National University Hospital
Current Primary Outcome: Fever duration [ Time Frame: within the first 14 days after intervention ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients improved in chest X-ray [ Time Frame: within the first 7 days after intervention ]
- Number of patients with side effect of steroid [ Time Frame: within the first 14 days after intervention ]
- Number of patients improved in chest X-ray [ Time Frame: within the first 14 days after intervention ]
Original Secondary Outcome: Same as current
Information By: Seoul National University Hospital
Dates:
Date Received: November 8, 2015
Date Started: June 2016
Date Completion: December 2018
Last Updated: October 12, 2016
Last Verified: October 2016