Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

NCT02303587 | Completed DMC

• 1 other identifier: BCHlung001
• Study Type: interventional
• Target: 424
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mycoplasma Pneumoniae Pneumonia

Keywords

Severe mycoplasma pneumoniae; pneumonia; children

Outcome Measures

Primary Outcomes (1)

• pulmonary lesions

  Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation

  6 months

Secondary Outcomes (9)

• recovery time of temperature

  2 weeks

• the proportion of absorption of pulmonary lesions

  2 weeks

• duration of hospitalization,

  2 weeks

• number of participant(s ) need intensive care

  2 weeks

• number of participant(s )with acute respiratory distress syndrome

  2 weeks

Study Arms (2)

low dose group

EXPERIMENTAL

methylprednisolone 2mg-4mg/Kg

Drug: methylprednisolone

high dose group

EXPERIMENTAL

methylprednisolone 10mg/Kg

Drug: methylprednisolone

Interventions

methylprednisolone DRUG

high dose group; low dose group

Eligibility Criteria

• Age: 29 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Beijing Children's Hospital: lead
• Shengjing Hospital: collaborator
• Children's Hospital of The Capital Institute of Pediatrics: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• Baoding Children's Hospital: collaborator

Study Sites (1)

Beijing Children's Hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Related Publications (11)

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

  BACKGROUND

• 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.

  PMID: 15646048 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18420275 BACKGROUND

• 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.

  PMID: 16119439 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22778084 BACKGROUND

• 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.

  PMID: 21395697 BACKGROUND

• 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.

  PMID: 21320122 BACKGROUND

• 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.

  PMID: 18656264 BACKGROUND

• 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.

  PMID: 32851257 DERIVED

MeSH Terms

Conditions

Pneumonia, Mycoplasma; Pneumonia

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Mycoplasma Infections; Mycoplasmatales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia, Bacterial; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Kunling Shen, MD,PhD

  Beijing Children's Hospital of Capital Medical University, China

  STUDY DIRECTOR

• Baoping Xu, MD, PhD

  Beijing Children's Hospital of Capital Medical University, China

  PRINCIPAL INVESTIGATOR

• Xiaoxia Peng, MD, PhD

  Beijing Children's Hospital of Capital Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Respiratory Department

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: December 1, 2014
• Study Start: December 1, 2014
• Primary Completion: October 16, 2019
• Study Completion: October 16, 2019
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)