Clinical Trials Directory

Trials / Unknown

UnknownNCT02618057

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children

Status
Unknown
Phase
Phase 4
Study type
Interventional
Enrollment
80 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGPrednisolonePO prednisolone, 1 mg/kg/day, for 5 days
DRUGLevofloxacinLevofloxacin, 10mg/kg/day, IV, for 5days

Timeline

Start date
2016-06-01
Primary completion
2020-12-01
Completion
2020-12-01
First posted
2015-12-01
Last updated
2018-04-27

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT02618057. Inclusion in this directory is not an endorsement.