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Mycoplasma Pneumoniae PneumoniaNCT02303587

Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

A study testing methylprednisolone in people with Mycoplasma Pneumoniae Pneumonia, run by Beijing Children's Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is designed to investigate difference in percentage of presentation of atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after discharge in those treated with a low dose regimen of methylprednisolone initiated with 2 or 4 mg/kg/d for 3 days followed by tapering, combined… Read more about this study

Who is it for?
Ages 29 days to 17 years
Conditions the study is for
Mycoplasma Pneumoniae Pneumonia
What is being tested?
methylprednisolone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
424 participants
Where
1 siteChina
Study dates
Dec 2014to 16 Oct 2019
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 29 days to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Severe pneumonia diagnosis criteria were based on the "Zhu Futang Practical Pediatrics" (the 7th Edition) and "the guideline of management of community-acquired pneumonia in children in China"(Chinese Journal of Pediatrics, 2013, 51:745-752, 856-862). Severe pneumonia is defined as pneumonia with one of the following:
  • Less than 18 years old
  • Severe pneumonia that is defined as pneumonia with one of the followings:
  • poor general condition
  • increased respiratory rate( infant>70/min，older children>50/min)
  • dyspnea
Show all 12Show fewer
  • cyanosis
  • multilobe involvement or ≥ 2/3 lung involvement
  • extrapulmonary complication
  • pleural effusion
  • Transcutaneous oxygen saturation in room air ≤92%
  • Serum M. pneumoniae antibody≥ 1:320, or serum M. pneumoniae antibody≥ 1:160 with positive PCR of M. pneumoniae or seroconversion (increased antibody titers ≥4 folds) Subject/Guardian is informed and consent.

Who cannot join

  • Subject will be excluded if she or he has one of the following:
  • evidence of bacterial pneumonia;
  • evidence of viral pneumonia;
  • evidence of fugal pneumonia;
  • evidence of pulmonary tuberculosis;
  • respiratory failure requiring mechanical ventilation;
Show all 22Show fewer
  • hemophagocytic syndrome;
  • liver failure or renal insufficiency;
  • congenital heart disease;
  • heart failure;
  • kidney disease;
  • connective tissue disease;
  • immunodeficiency;
  • tumor;
  • a history of hypertension or diabetes mellitus;
  • recurrent respiratory tract infection;
  • congenital bronchopulmonary dysplasia;
  • increased intraocular pressure;
  • history of use of glucocorticoids ≥1 week in previous 3 months;
  • having contraindications to glucocorticoids or azithromycin;
  • using of immunosuppressant before randomization;
  • undergoing trial for other medications or instruments.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Children's Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

Other trials in China

About this study

Official title: Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial

The study is designed to investigate difference in percentage of presentation of atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidation in 6 months after discharge in those treated with a low dose regimen of methylprednisolone initiated with 2 or 4 mg/kg/d for 3 days followed by tapering, combined with sequential treatment with azithromycin versus a high dose regimen of methylprednisolone initiated with 10 mg/kg/d for 3 days followed by tapering, combined with sequential treatment with azithromycin.

Read the detailed description

Mycoplasma pneumonia pneumonia (MPP) accounts for approximately 10-30% of childhood community-acquired pneumonia (CAP) in China. Macrolide is the first choice for MPP. However, progression to severe pneumonia might occur despite antibiotics therapy. And some patients have sequelae of bronchiolitis obliterans, bronchiectasis and atelectasis, et al. Based on inflammatory and immunological mechanism, there is some clinical evidence that adjuvant of corticosteroid reduced morbidity and improved the outcome in the children with severe MPP. However, the dosage of corticosteroid varied greatly in studies. Therefore, a large prospective study is needed to define the benefits of high-dose corticosteroid therapy in MPP.

Patients will be randomized into two groups: the low dose group and the high dose group. The low dose group will receive methylprednisolone 2 or 4 mg/kg/d for 3 days followed by tapering in 9 days, combined with sequential treatment with azithromycin. The high dose group will receive methylprednisolone 10 mg/kg/d for 3 days followed by tapering in 9 days, combined with sequential treatment with azithromycin. After discharge, patients of both groups will be followed up at 1, 3, and 6 months.

The number of pulmonary lesions, including atelectasis, bronchiectasis, bronchiolitis obliterans, or consolidations, in 6 months after discharge will be compared in two groups. The number of adverse events, such as hyperglycemia, hypertension, increased intraocular pressure, will be compared between the two groups.

The trial will be completed in 36 months, with 424 subjects recruited from 5 hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.

Being tested
methylprednisolone
Keywords
Severe mycoplasma pneumoniae, pneumonia, children
Medical subject headings
Pneumonia, Mycoplasma, Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02303587
Study groupRoleWhat they receive
low dose groupExperimentalmethylprednisolone 2mg-4mg/Kg
Receives: Drug: methylprednisolone
high dose groupExperimentalmethylprednisolone 10mg/Kg
Receives: Drug: methylprednisolone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pulmonary lesions

    Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation

    Measured: 6 months

Secondary outcomes (9)

  1. recovery time of temperature

    Measured: 2 weeks

  2. the proportion of absorption of pulmonary lesions

    Measured: 2 weeks

  3. duration of hospitalization,

    Measured: 2 weeks

  4. number of participant(s ) need intensive care

    Measured: 2 weeks

  5. number of participant(s )with acute respiratory distress syndrome

    Measured: 2 weeks

  6. number of participant(s) with hemophagocytic syndrome

    Measured: 2 weeks

  7. number of participant(s) with hyperglycemia

    Measured: 2 weeks

  8. number of participant(s) with hypertension

    Measured: 6 months

  9. number of participant(s) who died during the trial

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completion16 Oct 2019
  4. Study completion16 Oct 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
424 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02303587
Sponsor's protocol ID
BCHlung001
Status last verified
Jan 2021
First submitted
21 Nov 2014
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Chinese maternal and child health development report (2011). The Ministry of health of the people's Republic of China

  • Nagalingam NA, Adesiyun AA, Swanston WH, Bartholomew M. Prevalence of Mycoplasma pneumoniae and Chlamydia pneumoniae in pneumonia patients in four major hospitals in Trinidad. New Microbiol. 2004 Oct;27(4):345-51.

    PubMed 15646048

  • QIN Ming, TIAN Man, XIA Wen, ect. Etiology of community-acquired pneumonia in children.THE JOURNAL OF CLINICAL PEDIATRICS,2008,26(4):312-315.

  • Eun BW, Kim NH, Choi EH, Lee HJ. Mycoplasma pneumoniae in Korean children: the epidemiology of pneumonia over an 18-year period. J Infect. 2008 May;56(5):326-31. doi: 10.1016/j.jinf.2008.02.018. Epub 2008 Apr 16.

    PubMed 18420275

  • Gaillat J, Flahault A, deBarbeyrac B, Orfila J, Portier H, Ducroix JP, Bebear C, Mayaud C. Community epidemiology of Chlamydia and Mycoplasma pneumoniae in LRTI in France over 29 months. Eur J Epidemiol. 2005;20(7):643-51. doi: 10.1007/s10654-005-5868-9.

    PubMed 16119439

  • YU Zhen-xi, LIU Xiu-yun, JIANG Zai-fang. Analysis of relevant factors of severe mycoplasma pneumoniae pneumonia in acute phase in children. JOURNAL OF APPLIED CLINICAL PEDIATRICS, 2011，26（4）：246-249.

  • Zhang Q, Guo Z, Bai Z, MacDonald NE. A 4 year prospective study to determine risk factors for severe community acquired pneumonia in children in southern China. Pediatr Pulmonol. 2013 Apr;48(4):390-7. doi: 10.1002/ppul.22608. Epub 2012 Jul 6.

    PubMed 22778084

  • Hirao S, Wada H, Nakagaki K, Saraya T, Kurai D, Mikura S, Yasutake T, Higaki M, Yokoyama T, Ishii H, Nakata K, Aakashi T, Kamiya S, Goto H. Inflammation provoked by Mycoplasma pneumoniae extract: implications for combination treatment with clarithromycin and dexamethasone. FEMS Immunol Med Microbiol. 2011 Jul;62(2):182-9. doi: 10.1111/j.1574-695X.2011.00799.x. Epub 2011 Apr 11.

    PubMed 21395697

  • Shimizu T, Kida Y, Kuwano K. Cytoadherence-dependent induction of inflammatory responses by Mycoplasma pneumoniae. Immunology. 2011 May;133(1):51-61. doi: 10.1111/j.1365-2567.2011.03408.x. Epub 2011 Feb 14.

    PubMed 21320122

  • Tamura A, Matsubara K, Tanaka T, Nigami H, Yura K, Fukaya T. Methylprednisolone pulse therapy for refractory Mycoplasma pneumoniae pneumonia in children. J Infect. 2008 Sep;57(3):223-8. doi: 10.1016/j.jinf.2008.06.012. Epub 2008 Jul 25.

    PubMed 18656264

  • Xu B, Peng X, Yao Y, Yin J, Chen L, Liu J, Wang H, Gao L, Shen A, Shen K. Low-dose versus high-dose methylprednisolone for children with severe Mycoplasma pneumoniae pneumonia (MCMP): Study protocol for a randomized controlled trial. Pediatr Investig. 2018 Oct 17;2(3):176-183. doi: 10.1002/ped4.12041. eCollection 2018 Sep.

    PubMed 32851257

Questions about this trial

What is this clinical trial studying?

A study testing methylprednisolone in people with Mycoplasma Pneumoniae Pneumonia, run by Beijing Children's Hospital at 1 site in China.

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 12 inclusion and 22 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: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

pulmonary lesions (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02303587, which also lists 11 linked publications.

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 Jan 2021.

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