Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia

NCT ID: NCT02618057

Last Updated: 2018-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Mycoplasma Pneumoniae Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Steroid

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

Group Type EXPERIMENTAL

Prednisolone

Intervention Type DRUG

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

Levofloxacin

Intervention Type DRUG

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

Control

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

Group Type ACTIVE_COMPARATOR

Levofloxacin

Intervention Type DRUG

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

Interventions

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Prednisolone

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

Intervention Type DRUG

Levofloxacin

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

Intervention Type DRUG

Other Intervention Names

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Solondo

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eun Hwa Choi, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Children's Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Ki Wook Yun, M.D., Ph.D.

Role: CONTACT

82-2-2072-4909

Facility Contacts

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Ki Wook Yun, Prof.

Role: primary

82-2-2072-4909

Other Identifiers

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SNUH_P01

Identifier Type: -

Identifier Source: org_study_id

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