A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen

• Conditions: Pertussis; COPD Exacerbation

• Registration Number: NCT04694430
• Lead Sponsor: Shenzhen People's Hospital

Brief Summary

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.

Detailed Description

1. Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.

2. To explore the relationship between pertussis infection and COPD exacerbation.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-24
• Study Start: 2021-01-01
• Study First Submitted QC: 2021-01-04
• Last Update Submitted: 2021-01-04
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Clinical diagnosis of acute COPD

Exclusion Criteria

• Major diseases except COPD; 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the prevalence of pertussis among COPD	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 COPD.
Evaluation of the correlation between pertussis and COPD exacerbation	Day 0 of each subject at the time of enrollment.	Evaluate the correlation between pertussis infection and COPD exacerbation by pertussis positive rate and exacerbation degree.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the cut-off value for serological diagnosis of pertussis.	Day 0 of each subject at the time of enrollment.	By comparing the nucleic acid and antibody levels of Bordetella pertussis to evaluate the antibody cut-off value for serological diagnosis of pertussis.
Evaluation of the seroprevalence of Bordetella pertussis in COPD	Day 0 of each subject at the time of enrollment.	According to anti-pertussis (anti-PT) antibody levels, assess the overall seroprevalence of Bordetella pertussis in COPD.
Evaluation of the subtype of bordetella pertussis.	Day 0 of each subject at the time of enrollment.	According to the level and pattern of different anti-pertussis antibodies (anti-PT, anti-FHA, anti-PRN, anti-FIM2, anti-FIM3), assess the subtype of Bordetella pertussis.

Trial Locations

Locations (27)

Fuyong people's Hospital of Baoan District, Shenzhen; 🇨🇳 Shenzhen, China

General Hospital of Shenzhen University; 🇨🇳 Shenzhen, China

Longhua Branch of Shenzhen People's Hospital; 🇨🇳 Shenzhen, China

Nanshan District People's Hospital; 🇨🇳 Shenzhen, China

Peking university shenzhen hospital; 🇨🇳 Shenzhen, China

Shenzhen Bao'an District Central Hospital; 🇨🇳 Shenzhen, China

Shenzhen Bao'an District People's Hospital; 🇨🇳 Shenzhen, China

Shenzhen Hospital of Beijing University of traditional Chinese Medicine; 🇨🇳 Shenzhen, China

Shenzhen Hospital of Guangzhou University of traditional Chinese Medicine; 🇨🇳 Shenzhen, China

Shenzhen Hospital of Southern Medical University; 🇨🇳 Shenzhen, China

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