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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618057
Enrollment
80
Registered
2015-12-01
Start date
2016-06-30
Completion date
2020-12-31
Last updated
2018-04-27

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

Conditions

Mycoplasma Pneumoniae Pneumonia

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.

Interventions

DRUGPrednisolone

PO prednisolone, 1 mg/kg/day, for 5 days

DRUGLevofloxacin

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

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Fever durationwithin the first 14 days after intervention

Secondary

MeasureTime frame
Number of patients improved in chest X-raywithin the first 7 days after intervention
Number of patients with side effect of steroidwithin the first 14 days after intervention

Countries

South Korea

Contacts

Primary ContactKi Wook Yun, M.D., Ph.D.
pedwilly@gmail.com82-2-2072-4909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026