Mycoplasma pneumoniae pneumonia in children
Conditions
Interventions
Experiment:Qin Baiqing lung concentrated pill + azithromycin dry suspension analog agent
Control:Azithromycin dry suspension + Qin Baiqing lung concentrated pill analog agent
Sponsors
Beijing Children's Hospital affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1), aged between 3 and 14 years old (excluding 3 years old, including 14 years old), both outpatient or inpatient children can be used; (2) In line with the western diagnostic criteria of Mycoplasma pneumoniae in the eighth edition and the Expert Consensus on the Diagnosis and Treatment of Mycoplasma Pneumonia in Children (2015): 1) Fever and cough; 2) lung sounds; 3) Selected imaging showed: punctate or small patchy infiltrating shadows similar to lobular pneumonia, or interstitial changes similar to viral pneumonia. (3) Meet the TCM syndrome differentiation standard of wind-heat and closed-lung syndrome; (4) The blood routine is roughly normal, the total number of white blood cells (4.0~12.0) is 109 / L, and the neutrophil ratio is 50%~70%; (5) Course of disease (fever and / or cough symptoms, fever symptoms, i. e., axillary temperature 37.3?) for 7 days; (6), the VAS score of cough severity was 40mm within 24h before enrollment; (7) Rapid test positive for myco. pneumoniae; (8) The guardians of the selected children voluntarily sign the informed consent form, and the children aged 8 years old need to sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Children with acute infectious diseases such as measles and pertussis; (2) Children with severe malnutrition and immunodeficiency; (3) Children with pneumonia have complications, including pneumonia with respiratory failure, pneumonia with heart failure, pneumonia with toxic encephalopathy, gastrointestinal dysfunction, disseminated intravascular coagulation (DIC), respiratory distress syndrome, pneumonia with microcirculation disorder, and multiple organ failure; (4) Children with rapid disease progression (imaging shows more than 50% of inflammation progression within 24-48 hours); (5) Children with axillary temperature> 39.5?; (6) C-reactive protein (CRP)> 40mg / L; (7) Patients with pleural effusion, atelectasis, necrotizing pneumonia, lung abscess, pulmonary embolism, bacterial pneumonia, tuberculosis, bronchial foreign body and other severe lung lesions; (8) Children with severe primary diseases of heart, liver, kidney, hematopoietic system, nervous system, digestive system, metabolism and endocrine system; abnormal biochemical indicators: transaminase (ALT)> 1.5 times upper limit of normal, transaminase (AST)> 1.5 times upper limit of normal, creatinine (Cr); (9) Children known to be allergic to the ingredients of pulmonary concentrated pills or to azithromycin, erythromycin, other macrolides or ketolides; (10) Children with a history of abnormal liver function, hepatitis, liver necrosis, liver failure, and cholestatic jaundice / liver insufficiency after the previous use of azithromycin; (11) Previous treatment with azithromycin caused severe metamorphosis, including angioneurotic edema, anaphylactic shock reactions, skin reactions, including Stevens Johnson syndrome, toxic epidermal necrolysis, and eosinophilia and systemic symptoms (DRESS); (12) due to moderate to severe disease or risk factors is considered unsuitable for oral azithromycin treatment of children with pneumonia, such as cystic fibrosis, hospital acquired infection, confirmed or suspected bacteremia, weak, or major basic disease so that the body the ability to respond to the disease is impaired (including immune deficiency or functional spleen) children; (13) Children with previous azithromycin treatment for diarrhea caused by Clostridium difficile; (14) Children with ventricular repolarization, prolonged QT interval, arrhythmia, and torsade of ventricular tachycardia caused by previous application of macrolide antibiotics; (15) Children with macrolide or ketolides such as azithromycin, erythromycin, minocycline, doxycycline, levofloxacin, moxifloxacin, prednisone, methylprednisolone, and gamma globulin (IVIG) within 3 days before enrollment; (16) Children with Chinese patent medicine and decoction pieces with the efficacy of clearing away heat and detoxification, relieving cough and expectorant were used continuously within 3 days before enrollment; (17) Children who have participated in other clinical trials in the last three months; (18) Children considered unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical cure rate (symptoms, signs, laboratory tests, chest imaging).; | — |
Secondary
| Measure | Time frame |
|---|---|
| (8) The proportion of severe cases or ICU residents;;(2) Comprehensive efficacy;;(3) Time of cough disappearance;;(7) The curative effect of TCM syndrome;;(6) disappearance time of fever;;(4) cough relief time;;(1) Microbiological efficacy;;(5) VAS score of cough severity;;(9) Nucleic acid test results of Mycoplasma pneumoniae;;(10) M. pneumoniae culture rate and MP MIC50 MIC 90.; | — |
Countries
China
Contacts
Public ContactBaoping Xu
Beijing Children's Hospital affiliated to Capital Medical University
Outcome results
None listed