search
Back to results

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

Primary Purpose

Mycoplasma Pneumoniae Pneumonia

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Prednisolone
Levofloxacin
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mycoplasma Pneumoniae Pneumonia

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Steroid

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fever duration

Secondary Outcome Measures

Number of patients improved in chest X-ray
Number of patients with side effect of steroid
Number of patients improved in chest X-ray

Full Information

First Posted
November 8, 2015
Last Updated
April 26, 2018
Sponsor
Seoul National University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02618057
Brief Title
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
Official Title
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycoplasma Pneumoniae Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroid
Arm Type
Experimental
Arm Description
Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Levofloxacin, 10mg/kg/day, IV, for 5days
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
Solondo
Intervention Description
PO prednisolone, 1 mg/kg/day, for 5 days
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Intervention Description
Levofloxacin, 10mg/kg/day, IV, for 5days
Primary Outcome Measure Information:
Title
Fever duration
Time Frame
within the first 14 days after intervention
Secondary Outcome Measure Information:
Title
Number of patients improved in chest X-ray
Time Frame
within the first 7 days after intervention
Title
Number of patients with side effect of steroid
Time Frame
within the first 14 days after intervention
Title
Number of patients improved in chest X-ray
Time Frame
within the first 14 days after intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ki Wook Yun, M.D., Ph.D.
Phone
82-2-2072-4909
Email
pedwilly@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Hwa Choi, M.D., Ph.D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Children's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ki Wook Yun, Prof.
Phone
82-2-2072-4909
Email
pedwilly@snu.ac.kr

12. IPD Sharing Statement

Learn more about this trial

Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

We'll reach out to this number within 24 hrs