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

• Conditions: Chronic Cough; Pertussis
• Interventions: Procedure: Blood sample; Procedure: Data collection; Procedure: Throat swab

• Registration Number: NCT04694963
• Lead Sponsor: Shenzhen People's Hospital

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.

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

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

Exclusion Criteria

• 1. Major diseases except subaute cough; 2. Significant abnormality in laboratory examination; 3. Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; 4. Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10^9/L) within 4 weeks; 5. Currently suffering from active tuberculosis; 6. Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; 7. Patients who have undergone lung resection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subaute Cough	Data collection	N=500
Subaute Cough	Blood sample	N=500
Subaute Cough	Throat swab	N=500

Primary Outcome Measures

Name	Time	Method
Evaluation of the prevalence of pertussis among subacute cough	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	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 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 subacute cough	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 subacute cough.
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 (26)

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

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

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

Peking university shenzhen hospital; 🇨🇳 Shenzhen, China

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

General Hospital of Shenzhen University; 🇨🇳 Shenzhen, China

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

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

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

Shenzhen Hospital of the University of Hong Kong; 🇨🇳 Shenzhen, China

Shenzhen Longgang District Third People's Hospital; 🇨🇳 Shenzhen, China

Shenzhen Longhua District Central Hospital; 🇨🇳 Shenzhen, China

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

Shenzhen People's Hospital; 🇨🇳 Shenzhen, China

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

South University of science and Technology Hospital; 🇨🇳 Shenzhen, China

Shenzhen Longgang District Central Hospital; 🇨🇳 Shenzhen, China

Shenzhen Pingshan District Hospital of traditional Chinese Medicine; 🇨🇳 Shenzhen, China

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

Shenzhen Longgang District Second People's Hospital; 🇨🇳 Shenzhen, China

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

Shenzhen Qianhai Shekou Free Trade Zone Hospital; 🇨🇳 Shenzhen, China

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

The eighth Affiliated Hospital of Sun Yat sen University; 🇨🇳 Shenzhen, China

Shenzhen Second People's Hospital; 🇨🇳 Shenzhen, China

Shenzhen TCM Hospital; 🇨🇳 Shenzhen, China