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

Pertussis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04694963
• Other study ID #: WLW-SC-Pertussis
• Status: Not yet recruiting
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2020
• Source: Shenzhen People's Hospital
• Contact: Ronchan Chen
• Phone: 18002222009
• Email: chenrc[@]vip.163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Cough
• Cough
• Pertussis
• Whooping Cough

Intervention

Procedure:
• Blood sample
2 ml venous blood was collected and separated into serum.
• Data collection
Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination; Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;
• Throat swab
Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue. Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth. Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time.

Locations

Country	Name	City	State
China	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 Southern Medical University	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 Longgang District Second People's Hospital	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 Luohu District People's Hospital	Shenzhen
China	Shenzhen People's Hospital	Shenzhen
China	Shenzhen Pingshan District Hospital of traditional Chinese Medicine	Shenzhen
China	Shenzhen Pingshan District People's Hospital	Shenzhen
China	Shenzhen Qianhai Shekou Free Trade Zone Hospital	Shenzhen
China	Shenzhen Second People's Hospital	Shenzhen
China	Shenzhen TCM Hospital	Shenzhen
China	Shenzhen Yantian 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

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the prevalence of pertussis among subacute cough	According to the positive rate of bordetella pertussis nucleic acid, evaluate the prevalence of pertussis in subaute cough.	Day 0 of each subject at the time of enrollment.
Primary	Evaluation of the correlation between pertussis and subacute cough	Evaluate the correlation between pertussis infection and subacute cough by pertussis positive rate and clinical parameters.	Day 0 of each subject at the time of enrollment.
Secondary	Evaluation of the seroprevalence of bordetella pertussis in subacute cough	According to anti-pertussis (anti-PT) antibody levels, assess the overall seroprevalence of bordetella pertussis in subacute cough.	Day 0 of each subject at the time of enrollment.
Secondary	Evaluation of the cut-off value for serological diagnosis of pertussis.	By comparing the nucleic acid and antibody levels of Bordetella pertussis to evaluate the antibody cut-off value for serological diagnosis of pertussis.	Day 0 of each subject at the time of enrollment.
Secondary	Evaluation of the subtype of bordetella pertussis.	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.	Day 0 of each subject at the time of enrollment.