A Multi-center Study to Determine the Prevalence and Influence of Pertussis on Subacute Cough in Shenzhen
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
1 other identifier
observational
500
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJanuary 5, 2021
December 1, 2020
6 months
December 24, 2020
January 4, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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 Outcomes (3)
Evaluation of the 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.
Day 0 of each subject at the time of enrollment.
Evaluation of the subtype of bordetella pertussis.
Day 0 of each subject at the time of enrollment.
Study Arms (1)
Subaute Cough
N=500
Interventions
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;
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.
Eligibility Criteria
Patients with chronic cough in Shenzhen
You may qualify if:
- The cough lasts 3 to 8 weeks and there is no obvious evidence of lung disease on chest X-ray.
You may not qualify if:
- \. 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
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, China
Biospecimen
Throat swab, Peripheral blood
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lingwei Wang
Shenzhen People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2020
First Posted
January 5, 2021
Study Start
January 1, 2021
Primary Completion
June 30, 2021
Study Completion
December 31, 2021
Last Updated
January 5, 2021
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share