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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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