Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children - Full Text View

Sponsor:	Chongqing Medical University
Information provided by:	Chongqing Medical University
ClinicalTrials.gov Identifier:	NCT01217099

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

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone Sodium Phosphate Prednisolone phosphate Methylprednisolone Sodium Succinate Azithromycin Azithromycin dihydrate Azithromycin monohydrate

U.S. FDA Resources

Further study details as provided by Chongqing Medical University:

Primary Outcome Measures:

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 .

Secondary Outcome Measures:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217099

Sponsors and Collaborators

Chongqing Medical University

Investigators

Principal Investigator:

zhengxiu luo, doctor

Chongqing Medical University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

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:

Pleuropneumonia
Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Pleurisy
Pleural Diseases
Respiratory Tract Infections
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Methylprednisolone acetate
Prednisolone acetate

Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
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
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 24, 2012