NCT04126304

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,312 (estimated)
• Sponsor: Shanghai Children's Medical Center · Academic / Other
• Sex: All
• Age: 28 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Tract Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-28
• Primary completion: 2020-09-27
• Completion: 2021-05-31
• First posted: 2019-10-15
• Last updated: 2019-10-15

Regulatory

• FDA-regulated drug study