Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Mycoplasma Pneumoniae Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02618057
• Other study ID #: SNUH_P01
• Status: Recruiting
• Phase: Phase 4
• First received: November 8, 2015
• Last updated: April 26, 2018
• Start date: June 2016
• Est. completion date: December 2020

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: Ki Wook Yun, M.D., Ph.D.
• Phone: 82-2-2072-4909
• Email: pedwilly[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mycoplasma Infections
• Mycoplasma Pneumoniae Pneumonia
• Pleuropneumonia
• Pneumonia
• Pneumonia, Mycoplasma

Intervention

Drug:
• Prednisolone
PO prednisolone, 1 mg/kg/day, for 5 days
• Levofloxacin
Levofloxacin, 10mg/kg/day, IV, for 5days

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Children's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fever duration		within the first 14 days after intervention
Secondary	Number of patients improved in chest X-ray		within the first 7 days after intervention
Secondary	Number of patients with side effect of steroid		within the first 14 days after intervention
Secondary	Number of patients improved in chest X-ray		within the first 14 days after intervention