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Clinical Trials/NCT04694963
NCT04694963
Unknown
Not Applicable

A Integration of Respiratory Medicine and Prevention Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen by National Respiratory Diseases Clinical Medicine Research Center

Shenzhen People's Hospital26 sites in 1 country500 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pertussis
Sponsor
Shenzhen People's Hospital
Enrollment
500
Locations
26
Primary Endpoint
Evaluation of the prevalence of pertussis among subacute cough
Last Updated
5 years ago

Overview

Brief Summary

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of COPD pertussis and the impact of pertussis on subaute cough.

Detailed Description

1. Investigate the incidence and epidemiological characteristics of pertussis infection in subaute cough population. 2. To explore the relationship between pertussis infection and subaute cough.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
December 31, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shenzhen People's Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • The cough lasts 3 to 8 weeks and there is no obvious evidence of lung disease on chest X-ray.

Exclusion Criteria

  • Major diseases except subaute cough;
  • Significant abnormality in laboratory examination;
  • Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction;
  • Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10\^9/L) within 4 weeks;
  • Currently suffering from active tuberculosis;
  • Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis;
  • Patients who have undergone lung resection.

Outcomes

Primary Outcomes

Evaluation of the prevalence of pertussis among subacute cough

Time Frame: Day 0 of each subject at the time of enrollment.

According to the positive rate of bordetella pertussis nucleic acid, evaluate the prevalence of pertussis in subaute cough.

Evaluation of the correlation between pertussis and subacute cough

Time Frame: Day 0 of each subject at the time of enrollment.

Evaluate the correlation between pertussis infection and subacute cough by pertussis positive rate and clinical parameters.

Secondary Outcomes

  • Evaluation of the cut-off value for serological diagnosis of pertussis.(Day 0 of each subject at the time of enrollment.)
  • Evaluation of the seroprevalence of bordetella pertussis in subacute cough(Day 0 of each subject at the time of enrollment.)
  • Evaluation of the subtype of bordetella pertussis.(Day 0 of each subject at the time of enrollment.)

Study Sites (26)

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