Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children (MPP)
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Purpose
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) .
| Condition | Intervention |
|---|---|
|
Refractory Mycoplasma Pneumoniae Pneumonia |
Drug: methylprednisolone Drug: azithromycin |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children |
- efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ] [ Designated as safety issue: No ]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 .
- safety of methylprednisolone pulse macrolide therapy for children with refractory MPP. [ Time Frame: 3-year ] [ Designated as safety issue: Yes ]observe the further complications of infection between methylprednisolone pulse macrolide therapy group and macrolide therapy group .
| Enrollment: | 47 |
| Study Start Date: | May 2007 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: methylprednisolone
methylprednisolone pulse azithromycin
|
Drug: methylprednisolone
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
Other Name: treatment group
|
|
No Intervention: azithromycin
azithromycin
|
Drug: azithromycin
control patients were iv azithromycin for 5 days.
Other Name: control group
|
Detailed 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
Eligibility| Ages Eligible for Study: | 3 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | zhengxiu luo, Children's Hospital of Chongqing Medical University |
| ClinicalTrials.gov Identifier: | NCT01217099 History of Changes |
| Other Study ID Numbers: | ChiCTR-TRC2 |
| Study First Received: | October 6, 2010 |
| Last Updated: | October 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Chongqing Medical University:
|
refractory mycoplasma pneumoniae pneumonia |
Additional relevant MeSH terms:
|
Pneumonia, Mycoplasma Pneumonia Pneumonia, Bacterial Pleuropneumonia Mycoplasma Infections Lung Diseases Respiratory Tract Diseases Pleurisy Pleural Diseases Respiratory Tract Infections Mycoplasmatales Infections Gram-Negative Bacterial Infections Bacterial Infections Methylprednisolone acetate Prednisolone acetate |
Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone hemisuccinate Prednisolone phosphate Azithromycin Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 23, 2013