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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04694963
Enrollment
500
Registered
2021-01-05
Start date
2021-01-01
Completion date
2021-12-31
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pertussis, Chronic Cough

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.

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.

Interventions

PROCEDUREBlood sample

2 ml venous blood was collected and separated into serum.

PROCEDUREData 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;

PROCEDUREThroat 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.

Sponsors

Shenzhen People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of the prevalence of pertussis among subacute coughDay 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 coughDay 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

MeasureTime frameDescription
Evaluation of the seroprevalence of bordetella pertussis in subacute coughDay 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.

Countries

China

Contacts

Primary ContactRonchan Chen
chenrc@vip.163.com18002222009

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026