Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 3 for:    "Mycoplasma Pneumoniae Pneumonia" | "Neuroprotective Agents"
Previous Study | Return to List | Next Study

Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia (MCMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02303587
Recruitment Status : Unknown
Verified May 2017 by Baoping XU, Beijing Children's Hospital.
Recruitment status was:  Recruiting
First Posted : December 1, 2014
Last Update Posted : May 9, 2017
Sponsor:
Collaborators:
Shengjing Hospital
Capital Institute of Pediatrics, China
Changchun Children's Hospital
Women and Children's Health Hospital of yinchuan City
Shanxi Provincial Maternity and Children's Hospital
Information provided by (Responsible Party):
Baoping XU, Beijing Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Mycoplasma Pneumoniae Pneumonia Drug: methylprednisolone Not Applicable

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 35 months, with 630 subjects recruited from 9 hospitals in partnership with clinical research collaboration of National Clinical Research Center for Respiratory Diseases.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 630 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial
Study Start Date : December 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: low dose group
methylprednisolone 2mg-4mg/Kg
Drug: methylprednisolone
Experimental: high dose group
methylprednisolone 10mg/Kg
Drug: methylprednisolone



Primary Outcome Measures :
  1. pulmonary lesions [ Time Frame: 6 months ]
    Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation


Secondary Outcome Measures :
  1. recovery time of temperature [ Time Frame: 2 weeks ]
  2. the proportion of absorption of pulmonary lesions [ Time Frame: 2 weeks ]
  3. duration of hospitalization, [ Time Frame: 2 weeks ]
  4. number of participant(s ) need intensive care [ Time Frame: 2 weeks ]
  5. number of participant(s )with acute respiratory distress syndrome [ Time Frame: 2 weeks ]
  6. number of participant(s) with hemophagocytic syndrome [ Time Frame: 2 weeks ]
  7. number of participant(s) with hyperglycemia [ Time Frame: 2 weeks ]
  8. number of participant(s) with hypertension [ Time Frame: 6 months ]
  9. number of participant(s) who died during the trial [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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:

  1. Less than 18 years old
  2. 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%
  3. 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.

Exclusion Criteria:

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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02303587


Contacts
Layout table for location contacts
Contact: Baoping Xu, MD,PhD 861059616308 xubaopingbch@163.com

Locations
Layout table for location information
China, Beijing
Beijing Children's Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100045
Contact: baoping xu         
Sponsors and Collaborators
Beijing Children's Hospital
Shengjing Hospital
Capital Institute of Pediatrics, China
Changchun Children's Hospital
Women and Children's Health Hospital of yinchuan City
Shanxi Provincial Maternity and Children's Hospital
Investigators
Layout table for investigator information
Study Director: Kunling Shen, MD,PhD Beijing Children's Hospital of Capital Medical University, China
Principal Investigator: 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

Publications:
Chinese maternal and child health development report (2011). The Ministry of health of the people's Republic of China
QIN Ming, TIAN Man, XIA Wen, ect. Etiology of community-acquired pneumonia in children.THE JOURNAL OF CLINICAL PEDIATRICS,2008,26(4):312-315.
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.

Layout table for additonal information
Responsible Party: Baoping XU, Chief of Respiratory Department, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT02303587     History of Changes
Other Study ID Numbers: BCHlung001
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Baoping XU, Beijing Children's Hospital:
Severe mycoplasma pneumoniae
pneumonia
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Neuroprotective Agents
Mycoplasma Infections
Pneumonia, Mycoplasma
Pneumonia
Pleuropneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Pleurisy
Pleural Diseases
Mycoplasmatales Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Pneumonia, Bacterial
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists