Refractory Mycoplasma Pneumoniae PneumoniaMPPNCT01217099
Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
A study testing methylprednisolone and azithromycin in people with Refractory Mycoplasma Pneumoniae Pneumonia, run by Chongqing Medical University.
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) . Read more about this study
- Who is it for?
- Ages 3 to 11 years
- Conditions the study is for
- Refractory Mycoplasma Pneumoniae Pneumonia
- What is being tested?
- methylprednisolone and azithromycin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- May 2007to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mycoplasma pneumoniae pneumonia
- prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.
Who cannot join
- chronic cardiac and pulmonary disease
- immunodeficiency
- requiring mechanical ventilation
- with other pathogens detected during pneumonia.
About this study
Official title: A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
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) .
Read the 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
- Being tested
- methylprednisolone, azithromycin
- Keywords
- refractory mycoplasma pneumoniae pneumonia
- Medical subject headings
- Pneumonia, Mycoplasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called treatment group
treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
azithromycinDrug
Also called control group
control patients were iv azithromycin for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone | No intervention | methylprednisolone pulse azithromycin Receives: Drug: methylprednisolone |
| azithromycin | No intervention | azithromycin Receives: Drug: azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 3-year
Secondary outcomes (1)
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 .
Measured: 3-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2010 (estimated)
- Study startMay 2007
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Mycoplasma Pneumoniae PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- zhengxiu luo, doctor, Principal investigator, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01217099
- Sponsor's protocol ID
- ChiCTR-TRC2
- Acronym
- MPP
- Status last verified
- May 2007
- First submitted
- 6 Oct 2010
- Last updated
- 8 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Trial of Methylprednisolone Pulse Macrolide Therapy for Refractory Mycoplasma Pneumoniae Pneumonia in Children
- ClinicalTrials.gov ID
- NCT01217099
- Acronym / sponsor ID
- MPP / ChiCTR-TRC2
- Keywords
- refractory mycoplasma pneumoniae pneumonia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 8 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone | No intervention | Drug: methylprednisolonemethylprednisolone pulse azithromycin |
| azithromycin | No intervention | Drug: azithromycinazithromycin |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mycoplasma pneumoniae pneumonia
- prolonged fever and deterioration of radiological findings despite macrolides treatment for 7 days or more.
Key exclusion criteria (4 listed)
- chronic cardiac and pulmonary disease
- immunodeficiency
- requiring mechanical ventilation
- with other pathogens detected during pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: treatment grouptreatment patients were iv methylprednisolone pulse azithromycin for 5 days. | Drug | methylprednisolone |
| azithromycinAlso: control groupcontrol patients were iv azithromycin for 5 days. | Drug | azithromycin |
Primary outcome
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP.
Time frame: 3-year
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 .
1 secondary outcome
safety of methylprednisolone pulse macrolide therapy for children with refractory MPP.
Time frame: 3-year
Results and safety
The study was stopped early (reason given: terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2010.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhengxiu luo, doctor principal investigator
Chongqing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone and azithromycin in people with Refractory Mycoplasma Pneumoniae Pneumonia, run by Chongqing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: terminated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of methylprednisolone pulse macrolide therapy for children with refractory MPP. (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2010.