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

Sponsor

Shenzhen People's Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04694963

Collaborator

(none)

500

Enrollment

Locations

Anticipated Duration (Months)

19.2

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pertussis Chronic Cough	Procedure: Blood sample Procedure: Data collection Procedure: Throat swab

Detailed Description

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Subaute Cough N=500	Procedure: Blood sample 2 ml venous blood was collected and separated into serum. Procedure: 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; Procedure: 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.

Arm

Intervention/Treatment

Subaute Cough

N=500

Procedure: Blood sample

2 ml venous blood was collected and separated into serum.

Procedure: 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;

Procedure: 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.

Outcome Measures

Primary Outcome Measures

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

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 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Patients who have undergone lung resection.

Contacts and Locations

Locations

	Site	City	Country
1	Fuyong people's Hospital of Baoan District, Shenzhen	Shenzhen	China
2	General Hospital of Shenzhen University	Shenzhen	China
3	Longhua Branch of Shenzhen People's Hospital	Shenzhen	China
4	Nanshan District People's Hospital	Shenzhen	China
5	Peking university shenzhen hospital	Shenzhen	China
6	Shenzhen Bao'an District Central Hospital	Shenzhen	China
7	Shenzhen Bao'an District People's Hospital	Shenzhen	China
8	Shenzhen Hospital of Beijing University of traditional Chinese Medicine	Shenzhen	China
9	Shenzhen Hospital of Southern Medical University	Shenzhen	China
10	Shenzhen Hospital of the University of Hong Kong	Shenzhen	China
11	Shenzhen Longgang District Central Hospital	Shenzhen	China
12	Shenzhen Longgang District People's Hospital	Shenzhen	China
13	Shenzhen Longgang District Second People's Hospital	Shenzhen	China
14	Shenzhen Longgang District Third People's Hospital	Shenzhen	China
15	Shenzhen Longhua District Central Hospital	Shenzhen	China
16	Shenzhen Longhua District People's Hospital	Shenzhen	China
17	Shenzhen Luohu District People's Hospital	Shenzhen	China
18	Shenzhen People's Hospital	Shenzhen	China
19	Shenzhen Pingshan District Hospital of traditional Chinese Medicine	Shenzhen	China
20	Shenzhen Pingshan District People's Hospital	Shenzhen	China
21	Shenzhen Qianhai Shekou Free Trade Zone Hospital	Shenzhen	China
22	Shenzhen Second People's Hospital	Shenzhen	China
23	Shenzhen TCM Hospital	Shenzhen	China
24	Shenzhen Yantian District People's Hospital	Shenzhen	China
25	South University of science and Technology Hospital	Shenzhen	China
26	The eighth Affiliated Hospital of Sun Yat sen University	Shenzhen	China

Sponsors and Collaborators

Shenzhen People's Hospital

Investigators

Study Director: Lingwei Wang, Shenzhen People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shenzhen People's Hospital

ClinicalTrials.gov Identifier:

NCT04694963

Other Study ID Numbers:

WLW-SC-Pertussis

First Posted:

Jan 5, 2021

Last Update Posted:

Jan 5, 2021

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Whooping Cough

Cough

Study Results

No Results Posted as of Jan 5, 2021