PertussisNCT04694963
A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen
An observational study of Pertussis and Chronic Cough, run by Shenzhen People's Hospital at 26 sites in China.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pertussis, Chronic Cough
- What is being tested?
- Blood sample, Data collection and Throat swab
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 500 participants
- Where
- 26 sitesChina
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic cough in Shenzhen
Who may be able to join
- The cough lasts 3 to 8 weeks and there is no obvious evidence of lung disease on chest X-ray.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites
Fuyong people's Hospital of Baoan District, Shenzhen
Shenzhen
General Hospital of Shenzhen University
Shenzhen
Longhua Branch of Shenzhen People's Hospital
Shenzhen
Nanshan District People's Hospital
Shenzhen
Peking university shenzhen hospital
Shenzhen
Shenzhen Bao'an District Central Hospital
Shenzhen
Shenzhen Bao'an District People's Hospital
Shenzhen
Shenzhen Hospital of Beijing University of traditional Chinese Medicine
Shenzhen
Shenzhen Hospital of Southern Medical University
Shenzhen
Shenzhen Hospital of the University of Hong Kong
Shenzhen
Shenzhen Longgang District Central Hospital
Shenzhen
Shenzhen Longgang District People's Hospital
Shenzhen
Shenzhen Longgang District Second People's Hospital
Shenzhen
Shenzhen Longgang District Third People's Hospital
Shenzhen
Shenzhen Longhua District Central Hospital
Shenzhen
Shenzhen Longhua District People's Hospital
Shenzhen
Shenzhen Luohu District People's Hospital
Shenzhen
Shenzhen People's Hospital
Shenzhen
Shenzhen Pingshan District Hospital of traditional Chinese Medicine
Shenzhen
Shenzhen Pingshan District People's Hospital
Shenzhen
Shenzhen Qianhai Shekou Free Trade Zone Hospital
Shenzhen
Shenzhen Second People's Hospital
Shenzhen
Shenzhen TCM Hospital
Shenzhen
Shenzhen Yantian District People's Hospital
Shenzhen
South University of science and Technology Hospital
Shenzhen
The eighth Affiliated Hospital of Sun Yat sen University
Shenzhen
About this study
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
A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of COPD pertussis and the impact of pertussis on subaute cough.
Read the 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.
- Conditions
- Pertussis, Chronic Cough
- Being tested
- Blood sample, Data collection, Throat swab
- Medical subject headings
- Whooping Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleProcedure or surgery
2 ml venous blood was collected and separated into serum.
Data collectionProcedure or surgery
- 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 swabProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Subaute Cough | N=500 Receives: Procedure: Blood sample; Procedure: Data collection; Procedure: Throat swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 of each subject at the time of enrollment.
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.
Measured: Day 0 of each subject at the time of enrollment.
Secondary outcomes (3)
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.
Measured: Day 0 of each subject at the time of enrollment.
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.
Measured: Day 0 of each subject at the time of enrollment.
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.
Measured: Day 0 of each subject at the time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start1 Jan 2021 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lingwei Wang, Study director, Shenzhen People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04694963
- Sponsor's protocol ID
- WLW-SC-Pertussis
- Status last verified
- Dec 2020
- First submitted
- 24 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04694963
- Acronym / sponsor ID
- WLW-SC-Pertussis
- Conditions
- Pertussis, Chronic Cough
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shenzhen People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subaute Cough | – | Procedure: Blood sample, Procedure: Data collection, Procedure: Throat swabN=500 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic cough in Shenzhen
Key inclusion criteria (1 listed)
- The cough lasts 3 to 8 weeks and there is no obvious evidence of lung disease on chest X-ray.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample2 ml venous blood was collected and separated into serum. | Procedure or surgery | Subaute Cough |
| Data collection1. 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 or surgery | Subaute Cough |
| Throat swabBefore 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. | Procedure or surgery | Subaute Cough |
Primary outcome
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.
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.
3 secondary outcomes
Evaluation of the seroprevalence of bordetella pertussis in subacute cough
Time frame: 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.
Evaluation of the subtype of bordetella pertussis.
Time frame: Day 0 of each subject at the time of enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingwei Wang study director
Shenzhen People's Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis and Chronic Cough, run by Shenzhen People's Hospital at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronchan Chen (18002222009, chenrc@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the prevalence of pertussis among subacute cough (time frame: Day 0 of each subject at the time of enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.