Respiratory Tract Infections
Conditions
Keywords
community-acquired pneumonia, common cold, acute bronchitis, Post-infection cough, Mycoplasma infection rate, macrolides resistance
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.
Interventions
DRUGAzithromycin
If the diagnosis is common cold, acute bronchitis or post-infection cough ，treated with non-macrolides when the mycoplasma colloidal gold test is negative, treated with azithromycin when colloidal gold test is positive.
DRUGnon-macrolides antibiotics
If the diagnosis is community-acquired pneumonia with negative mycoplasma antibody-granule agglutination, non-macrolides are used for treatment
DIAGNOSTIC_TESTMycoplasma detection
1. common cold, acute bronchitis or post-infection cough :MPlgM colloidal gold detection;Pharyngeal swab MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection 2. community-acquired pneumonia:mycoplasma antigen antibody particle agglutination detection ;Sputum MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection
OTHERData collection
1. Common cold:On enrollment, day 3 and day 7, scores were collected based on the Canadian acute respiratory diseases and influenza scale (CARIFS scale), success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate. 2. Acute bronchitis :on enrollment, day 3, and day 7, the Likert 7 subscale was used to score the cough severity questionnaire, collect the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate. 3. Post-infection cough:on the day after outpatient visit, day 3, day 7, and day 14, the cough severity questionnaire (Likert 7 subscale) was used to score the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
Sponsors
Beijing Children's Hospital
Tianjin Children's Hospital
Xi 'an children's hospital
Shenzhen Children's Hospital
Third Affiliated Hospital of Zhengzhou University
Shanghai Children's Hospital
Children's Hospital of Chongqing Medical University
Wuhan Children's Hospital
The First Affiliated Hospital of Guangzhou Medical University
Shanghai Children's Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
28 Days to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MP infection rates | On enrollment 1 day | Respiratory illnesses include MP infection rates in children with outpatient (common cold, acute bronchitis, and chronic cough) and hospitalized (community-acquired pneumonia). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MP macrolides drug resistance gene rate | On enrollment 1 day | The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases |
| Sensitivity and specificity of MP rapid detection method | On enrollment 1 day | Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection |
| An early prediction model of refractory MP pneumonia | Community acquired pneumonia 30 days after discharge | An early prediction model of refractory MP pneumonia caused by MRMP was established |
| Clinical efficacy of azithromycin | Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days | Common cold and acute bronchitis on enrollment, day 3 and day 7;Post-infection cough on the day after outpatient visit, day 3, day 7, and day 14 |
Contacts
Primary ContactYong Yin, Master
Outcome results
None listed