Clinical trial NCT04126304: Mycoplasma Infection Rate and Macrolides Resistance in Children With Acute Respiratory Tract Infection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Tract Infections
Keywords: community-acquired pneumonia
common cold
acute bronchitis
Post-infection cough
Mycoplasma infection rate
macrolides resistance
Lead sponsor: Shanghai Children's Medical Center
Sponsor class: OTHER
Collaborators: name: Beijing Children's Hospital
name: Tianjin Children's Hospital
name: Xi 'an children's hospital
name: Shenzhen Children's Hospital
name: Third Affiliated Hospital of Zhengzhou University
name: Shanghai Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Wuhan Children's Hospital
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2019-10-15
Enrollment: 2312
Sex: ALL
Minimum age (years): 28
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The subjects of the study were outpatient patients at 8 centers including Shanghai children's medical center and hospitalized children at 6 centers on Oct. 28, 2019 and Sept. 27, 2020.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

A) age: over 28 days, under 18 years old; B) diagnosis: outpatient diagnosis of common cold, acute bronchitis or post-infection cough and hospitalization cases consistent with community-acquired pneumonia.

C) the guardian of the child (\< 8 years old) or the child (≥8 years old) can understand and be willing to participate in this study and sign a written informed consent.

Exclusion Criteria:

A)It is necessary to exclude underlying diseases associated with cardiovascular system, digestive system, nervous system, endocrine system, urinary system, immune system and genetic or chromosomal abnormalities.

B) the children or their families refused to participate in the study.

Primary outcomes:
measure: MP infection rates
timeFrame: On enrollment 1 day
Secondary outcomes:
measure: MP macrolides drug resistance gene rate
timeFrame: On enrollment 1 day
measure: Sensitivity and specificity of MP rapid detection method
timeFrame: On enrollment 1 day
measure: An early prediction model of refractory MP pneumonia
timeFrame: Community acquired pneumonia 30 days after discharge
measure: Clinical efficacy of azithromycin
timeFrame: Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Children's Medical Center
name: Yong Yin, master
role: PRINCIPAL_INVESTIGATOR
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