Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Phase 4

• Conditions: Mycoplasma Pneumoniae Pneumonia
• Interventions: Drug: Levofloxacin; Drug: Prednisolone

• Registration Number: NCT02618057
• Lead Sponsor: Seoul National University Hospital

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 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.

Study Timeline

• Study First Submitted: 2015-11-08
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Study Start: 2016-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-27
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Evidence of Mycoplasma pneumoniae infection
• Lobar pneumonia or pneumoniae with pleural effusion

Exclusion Criteria

• Immunosuppresant host
• Chronic cardiovascular/pulmonary disease
• Hospital acquired infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Levofloxacin	Levofloxacin, 10mg/kg/day, IV, for 5days
Steroid	Levofloxacin	Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
Steroid	Prednisolone	Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days

Primary Outcome Measures

Name	Time	Method
Fever duration	within the first 14 days after intervention

Secondary Outcome Measures

Name	Time	Method
Number of patients improved in chest X-ray	within the first 14 days after intervention
Number of patients with side effect of steroid	within the first 14 days after intervention

Trial Locations

Locations (1)

Seoul National University Children's Hospital; 🇰🇷 Seoul, Korea, Republic of