Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia | NCT02618057

Studies
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

NCT02618057

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Apr 27, 2018Actual

Enrollment

80Estimated

Phase

Phase 4

Conditions

Mycoplasma Pneumoniae Pneumonia

Interventions

Prednisolone
Levofloxacin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Nov 8, 2015

First Submission Date that Met QC Criteria

Nov 25, 2015

First Posted Date

Dec 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2018

Last Update Posted Date

Apr 27, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Steroid	Experimental	Prednisolone, 1.0 mg/kg/day, PO, for 5 days Levofloxacin, 10mg/kg/day, IV, for 5days	Drug: Prednisolone Drug: Levofloxacin
Control	Active Comparator	Levofloxacin, 10mg/kg/day, IV, for 5days	Drug: Levofloxacin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prednisolone	Drug	PO prednisolone, 1 mg/kg/day, for 5 days	Steroid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fever duration		within the first 14 days after intervention

Secondary Outcomes

Measure	Description	Time Frame
Number of patients improved in chest X-ray		within the first 7 days after intervention
Number of patients with side effect of steroid		within the first 14 days after intervention

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ki Wook Yun, M.D., Ph.D.	Contact	82-2-2072-4909		pedwilly@gmail.com

Overall Officials

Name	Affiliation	Role
Eun Hwa Choi, M.D., Ph.D.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Children's Hospital	Recruiting	Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D011019	Pneumonia, Mycoplasma

Ancestor Terms

ID	Term
D009175	Mycoplasma Infections
D009180	Mycoplasmatales Infections
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011239	Prednisolone
D064704	Levofloxacin

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided