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

NCT04126304 | Unknown DMC FDA Drug

• 1 other identifier: SCMCIRB-K2019060-1
• Study Type: observational
• Target: 2,312
• Locations: 0 countries
• Sites: N/A

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

Conditions

Respiratory Tract Infections

Keywords

community-acquired pneumonia; common cold; acute bronchitis; Post-infection cough; Mycoplasma infection rate; macrolides resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• MP macrolides drug resistance gene rate

  On enrollment 1 day

• Sensitivity and specificity of MP rapid detection method

  On enrollment 1 day

• An early prediction model of refractory MP pneumonia

  Community acquired pneumonia 30 days after discharge

• Clinical efficacy of azithromycin

  Common cold and acute bronchitis for 7 days ;Post-infection cough for 14 days

Study Arms (4)

Common cold

A cold is a clinical diagnosis.Complaints may include a stuffy nose, sore throat, cough and headache.Objective signs are rare, but may include fever, enlarged anterior cervical lymph nodes, nasal mucosa and oropharyngeal erythema, and nasal mucus.

Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection

acute bronchitis

In 2011, the European society of respiratory diseases (ERS) defined acute disease in patients with non-chronic lung disease. Symptoms include cough, with or without expectoration of phlegm, and other symptoms and signs may indicate lower respiratory tract infection and cannot be explained by other diseases (e.g., sinusitis, asthma).The main symptoms of acute bronchitis are cough, may be accompanied by fever, fatigue, asthma and dyspnea.

Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection

Post-infection cough

The definition in the 2013 guidelines for diagnosis and treatment of chronic cough in Chinese children: cough refers to a recent history of respiratory tract infection;The cough lasted \> for 4 weeks, presenting an irritating dry cough or a little white phlegm.Chest x - ray examination showed no abnormality or only increased lung veins.The pulmonary ventilation function was normal, or presented transient high airway response.Coughs are usually self-limited, and other diagnoses should be considered if the cough is more than 8 weeks old.In addition to other causes of chronic cough.

Drug: Azithromycin; Diagnostic Test: Mycoplasma detection; Other: Data collection

community-acquired pneumonia

According to the 2019 guidelines for the diagnosis and treatment of community-acquired pneumonia in children, it is defined as infectious pneumonia developed outside the hospital (community), including pneumonia developed after admission due to infection of pathogens with a clear incubation period outside the hospital (community).

Drug: non-macrolides antibiotics; Diagnostic Test: Mycoplasma detection; Other: Data collection

Interventions

Azithromycin DRUG

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.

Common cold; Post-infection cough; acute bronchitis

non-macrolides antibiotics DRUG

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

community-acquired pneumonia

Mycoplasma detection DIAGNOSTIC_TEST

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

Common cold; Post-infection cough; acute bronchitis; community-acquired pneumonia

Data collection OTHER

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.

Common cold; Post-infection cough; acute bronchitis

Eligibility Criteria

• Age: 28 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Children's Medical Center: lead
• Beijing Children's Hospital: collaborator
• Tianjin Children's Hospital: collaborator
• Xi 'an children's hospital: collaborator
• Shenzhen Children's Hospital: collaborator
• Third Affiliated Hospital of Zhengzhou University: collaborator
• Shanghai Children's Hospital: collaborator
• Children's Hospital of Chongqing Medical University: collaborator
• Wuhan Children's Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator

Related Publications (18)

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Biospecimen

Retention: SAMPLES WITH DNA

Blood samples Pharyngeal swab Sputum samples

MeSH Terms

Conditions

Respiratory Tract Infections; Community-Acquired Pneumonia; Common Cold; Bronchitis

Interventions

Azithromycin; Data Collection

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Community-Acquired Infections; Pneumonia; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Yong Yin, master

  Shanghai Children's Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Yin, Master

CONTACT

18930830705; E-mail:yinyong9999@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2019
• First Posted: October 15, 2019
• Study Start: November 28, 2019
• Primary Completion: September 27, 2020
• Study Completion: May 31, 2021
• Last Updated: October 15, 2019

Record last verified: 2019-10