NCT01217099

Brief 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) .

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
Last Updated

October 8, 2010

Status Verified

May 1, 2007

Enrollment Period

3 years

First QC Date

October 6, 2010

Last Update Submit

October 7, 2010

Conditions

Keywords

refractory mycoplasma pneumoniae pneumonia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.

    3-year

Study Arms (2)

methylprednisolone

NO INTERVENTION

methylprednisolone pulse azithromycin

Drug: methylprednisolone

azithromycin

NO INTERVENTION

azithromycin

Drug: azithromycin

Interventions

treatment patients were iv methylprednisolone pulse azithromycin for 5 days.

Also known as: treatment group
methylprednisolone

control patients were iv azithromycin for 5 days.

Also known as: control group
azithromycin

Eligibility Criteria

Age3 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • chronic cardiac and pulmonary disease
  • immunodeficiency
  • requiring mechanical ventilation
  • with other pathogens detected during pneumonia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Pneumonia, Mycoplasma

Interventions

MethylprednisoloneAzithromycinControl Groups

Condition Hierarchy (Ancestors)

Mycoplasma InfectionsMycoplasmatales InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsPneumonia, BacterialPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsErythromycinMacrolidesPolyketidesLactonesOrganic ChemicalsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • zhengxiu luo, doctor

    Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 8, 2010

Study Start

May 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 8, 2010

Record last verified: 2007-05