Epidemiological characteristics of respiratory tract infection caused by atypical pathogens among primary care patients

Not Applicable

Recruiting

• Conditions: Respiratory tract infection/atypical pathogen/Mycoplasma pneumoniae/Chlamydophila pneumoniae/Bordetella pertussis/Bordetella paraperutussis

• Registration Number: JPRN-UMIN000035346
• Lead Sponsor: Tsukuba Medical Center Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Not provided

Exclusion Criteria

Patients are excluded if one of the following criteria is met. 1) Patients or proxies are unable to provide informed consent in Japanese 2) Patients have severe conditions (e.g., altered mental status and shock state), and sample collections are unable to be performed safely 3) Patients have chronic lung disease with multiple episodes of acute exacerbation 4) Patients have clinically evident sinusitis or tonsillitis with tonsillar exudate and swelling 5) Patients have lung tuberculosis, lung mycosis, or nontuberculous mycobacterial lung disease 6) Patients are diagnosed with hospital-acquired pneumonia or healthcare-associated pneumonia 7) Patients have dysphagia or a history of aspiration 8) Patients have obstructive pneumonia, empyema, or lung abscess

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The epidemiological characteristics of respiratory tract infection caused by atypical pathogens (Mycoplasma pneumoniae, Chlamydophila pneumoniae, Chlamydophila psittasi, Bordetella pertussis, Bordetella parapertussis).

Secondary Outcome Measures

Name	Time	Method
1) The sensitivity, specificity, positive/negative predictive value, and odds ratio of the clinical signs and symptoms for the diagnosis of respiratory infection caused by different atypical pathogens. 2) The agreement between the clinical disease probabilities of atypical pathogen infection assessed by the treating physicians and the results of molecular examinations. 3) The changes in the reliability of disease probabilities assessed by the treating physicians during the study period. 4) The differences in the antimicrobial prescription patterns between patients with positive and negative test results for atypical pathogens. 5) The differences in the antimicrobial prescription patterns between Mycoplasma pneumoniae patients with and without the macrolide resistance associated mutation. 6) The sensitivity, specificity, positive/negative predictive value and odds ratio of the Heckerling clinical decision rule for the diagnosis of community-acquired pneumonia.