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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04126304
• Other study ID #: SCMCIRB-K2019060-1
• Status: Not yet recruiting
• Start date: November 28, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: October 2019
• Source: Shanghai Children's Medical Center
• Contact: Yong Yin, Master
• Phone: 18930830705
• Email: E-mail:yinyong9999[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2312
• Est. completion date: May 31, 2021
• Est. primary completion date: September 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Mycoplasma Infections
• Pleuropneumonia
• Respiratory Tract Infections

Intervention

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.
• 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
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 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
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. 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. 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.
• 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

Locations

Country	Name	City	State
n/a

Sponsors (10)

Lead Sponsor	Collaborator
Shanghai Children's Medical Center	Beijing Children's Hospital, Children's Hospital of Chongqing Medical University, Shanghai Children's Hospital, Shenzhen Children's Hospital, The First Affiliated Hospital of Guangzhou Medical University, Third Affiliated Hospital of Zhengzhou University, Tianjin Children's Hospital, Wuhan Children's Hospital, Xi 'an children's hospital

References & Publications (18)

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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MP infection rates	Respiratory illnesses include MP infection rates in children with outpatient (common cold, acute bronchitis, and chronic cough) and hospitalized (community-acquired pneumonia).	On enrollment 1 day
Secondary	MP macrolides drug resistance gene rate	The detection rate of MP macrolides drug resistance gene was isolated from respiratory disease cases	On enrollment 1 day
Secondary	Sensitivity and specificity of MP rapid detection method	Sensitivity and specificity of MP rapid detection method (antigen and antibody detection rapid colloidal gold method) for diagnosis of MP infection	On enrollment 1 day
Secondary	An early prediction model of refractory MP pneumonia	An early prediction model of refractory MP pneumonia caused by MRMP was established	Community acquired pneumonia 30 days after discharge
Secondary	Clinical efficacy of azithromycin	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	Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days