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Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

NCT ID: NCT01217099

Last Updated: 2010-10-08

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

TERMINATED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia(MPP) .

Detailed Description

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Corticosteroid has been used in adulthood refractory MPP with satisfactory efficacy. But there were few studies about the use of corticosteroid in children with refractory MPP. Lee KY et al indicated oral prednisolone of 1 mg/kg/ day for 1 week be useful for children with severe MPP. Akihiro T et al demonstrated that intravenously administered methylprednisolone at a dose of 30 mg/kg once daily for 3 consecutive days had an efficacious treatment for children with refractory MPP.But the methods of corticosteroid use, such as the dosage, administration route, duration of treatment have not been well understood. So in this study, we planned to investigate whether small doses of methylprednisolone pulse macrolide therapy can relieve symptoms,chest X-rays faster than macrolide alone therapy for refractory mycoplasma pneumoniae pneumonia in a prospective, open-label fashion.

PMID: 11096025 PMID: 18033831 PMID: 10434547 PMID: 16437541 PMID: 18656264

Conditions

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Refractory Mycoplasma Pneumoniae Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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methylprednisolone

methylprednisolone pulse azithromycin

Group Type NO_INTERVENTION

methylprednisolone

Intervention Type DRUG

treatment patients were iv methylprednisolone pulse azithromycin for 5 days.

azithromycin

azithromycin

Group Type NO_INTERVENTION

azithromycin

Intervention Type DRUG

control patients were iv azithromycin for 5 days.

Interventions

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methylprednisolone

treatment patients were iv methylprednisolone pulse azithromycin for 5 days.

Intervention Type DRUG

azithromycin

control patients were iv azithromycin for 5 days.

Intervention Type DRUG

Other Intervention Names

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treatment group control group

Eligibility Criteria

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Inclusion Criteria

* mycoplasma pneumoniae pneumonia
* prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.

Exclusion Criteria

* chronic cardiac and pulmonary disease
* immunodeficiency
* requiring mechanical ventilation
* with other pathogens detected during pneumonia.
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Children's Hospital of Chongqing Medical University

Principal Investigators

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zhengxiu luo, doctor

Role: PRINCIPAL_INVESTIGATOR

Chongqing Medical University

Related Links

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http://www.clinicaltrials.gov

Related Info

Other Identifiers

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ChiCTR-TRC2

Identifier Type: -

Identifier Source: org_study_id