Mycoplasma Infection Rate and Macrolides Resistance in Children With Acute Respiratory Tract Infection

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

Conditions

• Respiratory Tract Infections

Interventions

DRUG

Azithromycin

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.

DRUG

non-macrolides antibiotics

If the diagnosis is community-acquired pneumonia with negative mycoplasma antibody-granule agglutination, non-macrolides are used for treatment

DIAGNOSTIC_TEST

Mycoplasma 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

OTHER

Data 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.

OTHER

Data collection

Acquisition of children hospitalized time, heating time, mixed infection, drug (azithromycin, tetracycline, quinolone) dose and use time, pulmonary complication (pleural effusion, atelectasis, necrotizing pneumonia, interstitial pneumonia, occlusive bronchitis, occlusive bronchiolitis, lung, emphysema, lung abscess, bronchiectasis, transparent), pleural puncture/drainage, bronchoscope, oxygen time, into the ICU, mechanical ventilation time, surgery, and deaths and re-visit, hospitalization, surgery and death within 30 days after discharge

Sponsors & Collaborators

• Shanghai Children's Hospital

  collaborator OTHER

• Children's Hospital of Chongqing Medical University

  collaborator OTHER

• Wuhan Children's Hospital

  collaborator OTHER

• Beijing Children's Hospital

  collaborator OTHER

• Tianjin Children's Hospital

  collaborator OTHER

• Xi 'an children's hospital

  collaborator UNKNOWN

• Shenzhen Children's Hospital

  collaborator OTHER_GOV

• Third Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Shanghai Children's Medical Center

  lead OTHER

Principal Investigators

• Yong Yin, master · Shanghai Children's Medical Center

Eligibility

Min Age

28 Days

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-11-28

Primary Completion

2020-09-27

Completion

2021-05-31

FDA Drug

Yes