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

January 4, 2021 updated by: Shenzhen People's Hospital

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

A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of COPD pertussis and the impact of pertussis on subaute cough.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shenzhen, China
        • Peking University Shenzhen Hospital
      • Shenzhen, China
        • Shenzhen Second People's Hospital
      • Shenzhen, 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
        • 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 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic cough in Shenzhen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subaute Cough
N=500
Procedure: Blood sample
2 ml venous blood was collected and separated into serum.
Procedure: Data collection
  1. Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
  2. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the prevalence of pertussis among subacute cough
Time Frame: 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.
Day 0 of each subject at the time of enrollment.
Evaluation of the correlation between pertussis and subacute cough
Time Frame: 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.
Day 0 of each subject at the time of enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the seroprevalence of bordetella pertussis in subacute cough
Time Frame: 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.
Day 0 of each subject at the time of enrollment.
Evaluation of the cut-off value for serological diagnosis of pertussis.
Time Frame: 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.
Day 0 of each subject at the time of enrollment.
Evaluation of the subtype of bordetella pertussis.
Time Frame: 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.
Day 0 of each subject at the time of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

December 24, 2020

First Submitted That Met QC Criteria

January 4, 2021

First Posted (Actual)

January 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 5, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WLW-SC-Pertussis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pertussis

Clinical Trials on Blood sample

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe