Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Seoul National University

Status and phase: Unknown; Phase 4

Conditions: Mycoplasma Pneumoniae Pneumonia

Treatments: Drug: Prednisolone; Drug: Levofloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT02618057

SNUH_P01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Steroid

Experimental group

Description:

Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days

Treatment:

Drug: Levofloxacin

Drug: Prednisolone

Control

Active Comparator group

Description:

Levofloxacin, 10mg/kg/day, IV, for 5days

Treatment:

Drug: Levofloxacin