Mycoplasma Pneumoniae Pneumonia Clinical Trial
Official title:
Low Dose Versus High Dose Methylprednisolone for Children With Severe Mycoplasma Pneumoniae Pneumonia : a Multicenter Randomized Blinded Trial
Verified date | January 2021 |
Source | Beijing Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 424 |
Est. completion date | October 16, 2019 |
Est. primary completion date | October 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Children's Hospital, Capital Medical University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Children's Hospital | Baoding Children's Hospital, Children's Hospital of The Capital Institute of Pediatrics, Shanxi Provincial Maternity and Children's Hospital, Shengjing Hospital |
China,
Chinese maternal and child health development report (2011). The Ministry of health of the people's Republic of China
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. Erratum in: J Infect. 2011 Oct;63(4):320. — View Citation
Gaillat J, Flahault A, deBarbeyrac B, Orfila J, Portier H, Ducroix JP, Bébéar 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. — View Citation
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. — View Citation
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. — View Citation
QIN Ming, TIAN Man, XIA Wen, ect. Etiology of community-acquired pneumonia in children.THE JOURNAL OF CLINICAL PEDIATRICS,2008,26(4):312-315.
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pulmonary lesions | Pulmonary lesions include atelectasis, bronchiectasia, bronchiolitis obliterans, consolidation | 6 months | |
Secondary | recovery time of temperature | 2 weeks | ||
Secondary | the proportion of absorption of pulmonary lesions | 2 weeks | ||
Secondary | duration of hospitalization, | 2 weeks | ||
Secondary | number of participant(s ) need intensive care | 2 weeks | ||
Secondary | number of participant(s )with acute respiratory distress syndrome | 2 weeks | ||
Secondary | number of participant(s) with hemophagocytic syndrome | 2 weeks | ||
Secondary | number of participant(s) with hyperglycemia | 2 weeks | ||
Secondary | number of participant(s) with hypertension | 6 months | ||
Secondary | number of participant(s) who died during the trial | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT06348095 -
Effect of Probiotics on Mycoplasma Pneumoniae Pneumonia
|
N/A | |
Recruiting |
NCT02618057 -
Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
|
Phase 4 | |
Not yet recruiting |
NCT04296383 -
Xiyanping Injection Combined With Azithromycin VS Azithromycin for Children With pneumoniaProtozoal Pneumonia
|
N/A | |
Not yet recruiting |
NCT06325293 -
A Trial of Placebo Versus Macrolide for Mycoplasma Pneumoniae Childhood Pneumonia: MYTHIC Study
|
N/A |