Respiratory Tract Infections Clinical Trial
Official title:
Multi-center Investigation and Study of Mycoplasma Pneumoniae Infection and Macrolide Drug Resistance in Outpatient and In-hospital Pediatric Acute Respiratory Diseases Illness in China
In recent years, mycoplasma pneumoniae caused more than 30% of respiratory infections in
children in China, among which the detection rate of drug-resistant mycoplasma pneumoniae was
higher than 90%. Pediatricians are facing great challenges.
In this study, a total of 2312 clinical cases were expected to be collected, including 1160
cases of outpatient respiratory infection including common cold, acute bronchitis and cough
after infection, and 1152 cases of hospitalized community-acquired pneumonia, through uniform
enrollment in 11 multi-centers for 1 year. Clinical data and respiratory samples were
collected and clinical follow-up was completed.To investigate the infection rate and drug
resistance gene of mycoplasma pneumoniae in children's respiratory tract infection.To
evaluate the effectiveness of azithromycin in the treatment of mycoplasma pneumoniae
respiratory infection.The early prediction model of refractory mycoplasma pneumoniae was
established.To explore the clinical value of colloidal gold in early diagnosis of mycoplasma
pneumoniae infection
This research center is a cross-sectional investigation and study, 8 centers including
Shanghai children's medical center recruit the outpatient respiratory infection cases into
the group, 6 centers including Shanghai children's medical recruit children with
community-acquired pneumonia in hospital into the group All of the above cases in the group
relevant clinical datas are collected, and complete clinical follow-up.Pharyngeal swabs or
sputum specimens collected during the study were sent to Shanghai children's medical center
for the detection of MP and macrolidene drug resistance genes.
Azithromycin was administered orally or intravenously to outpatients who tested positive for
mycoplasma pneumoniae by colloidal gold method.Finally, MP infection rate of children with
respiratory diseases including outpatient (common cold, acute bronchitis and cough after
infection) and hospitalization (community-acquired pneumonia) was statistically observed.The
detection rate of MP macrolides drug resistance gene was isolated from respiratory disease
cases.Sensitivity and specificity of MP rapid detection method (antigen and antibody
detection rapid colloidal gold method) for diagnosis of MP infection;Effectiveness of
azithromycin in treatment of MRMP infection.
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