Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Refractory Mycoplasma Pneumoniae Pneumonia Clinical Trial

— MPP  

Official title:

A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01217099
• Other study ID #: ChiCTR-TRC2
• Status: Terminated
• Phase: N/A
• First received: October 6, 2010
• Last updated: October 7, 2010
• Start date: May 2007
• Est. completion date: May 2010

Study information

• Verified date: May 2007
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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) .

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 47
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• methylprednisolone
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
• azithromycin
control patients were iv azithromycin for 5 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.	compare the temperature , infiltration absorption,atelectasis resolution, pleural effusion disappearance,serum levels of ferritin and LDH between methylprednisolone pulse macrolide therapy group and macrolide therapy group .	3-year	No
Secondary	safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.	observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .	3-year	Yes

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