A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen
- Conditions
- PertussisCOPD Exacerbation
- Interventions
- Procedure: Blood sampleOther: Data collectionProcedure: Throat swab
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- Clinical diagnosis of acute COPD
- 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
- Arm && Interventions
Group Intervention Description Severe exacerbation of COPD Throat swab N = 250 Mild and moderate exacerbations of COPD Data collection N = 250 Severe exacerbation of COPD Data collection N = 250 Mild and moderate exacerbations of COPD Throat swab N = 250 Mild and moderate exacerbations of COPD Blood sample N = 250 Severe exacerbation of COPD Blood sample N = 250
- 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
Shenzhen Bao'an District People's Hospital
🇨🇳Shenzhen, China
Shenzhen Hospital of Guangzhou University of traditional Chinese Medicine
🇨🇳Shenzhen, China
Shenzhen People's Hospital
🇨🇳Shenzhen, China
Shenzhen Yantian District People's Hospital
🇨🇳Shenzhen, China
Shenzhen Bao'an District Central Hospital
🇨🇳Shenzhen, China
Shenzhen Hospital of the University of Hong Kong
🇨🇳Shenzhen, China
Shenzhen Longgang District Central Hospital
🇨🇳Shenzhen, China
Shenzhen Longgang District People's Hospital
🇨🇳Shenzhen, China
Shenzhen Longhua District People's Hospital
🇨🇳Shenzhen, China
Shenzhen Pingshan District Hospital of traditional Chinese Medicine
🇨🇳Shenzhen, China
Shenzhen Qianhai Shekou Free Trade Zone Hospital
🇨🇳Shenzhen, China
Nanshan District People's Hospital
🇨🇳Shenzhen, China
Peking university shenzhen hospital
🇨🇳Shenzhen, China
Longhua Branch of Shenzhen People's Hospital
🇨🇳Shenzhen, China
Shenzhen Longgang District Second People's Hospital
🇨🇳Shenzhen, China
Shenzhen Luohu District People's Hospital
🇨🇳Shenzhen, China
General Hospital of Shenzhen University
🇨🇳Shenzhen, China
Shenzhen Hospital of Beijing University of traditional Chinese Medicine
🇨🇳Shenzhen, China
Shenzhen Hospital of Southern Medical University
🇨🇳Shenzhen, China
Shenzhen Longgang District Third People's Hospital
🇨🇳Shenzhen, China
Shenzhen Second People's Hospital
🇨🇳Shenzhen, China
Shenzhen TCM Hospital
🇨🇳Shenzhen, China
Shenzhen Longhua District Central Hospital
🇨🇳Shenzhen, China
Shenzhen Pingshan District People's Hospital
🇨🇳Shenzhen, China
South University of science and Technology Hospital
🇨🇳Shenzhen, China
The eighth Affiliated Hospital of Sun Yat sen University
🇨🇳Shenzhen, China