COPD ExacerbationNCT04694430
A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen
An observational study of COPD Exacerbation and Pertussis, run by Shenzhen People's Hospital at 27 sites in China.
Trial summary
A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- COPD Exacerbation, Pertussis
- What is being tested?
- Blood sample, Data collection and Throat swab
- Type of treatment
- Vaccines, Surgery or procedure
- How many people
- 500 participants
- Where
- 27 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 acute COPD in Shenzhen
Who may be able to join
- Clinical diagnosis of acute COPD
Who cannot join
- Major diseases except COPD; Significant abnormality in laboratory examination; Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10^9/L) within 4 weeks; Currently suffering from active tuberculosis; Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; Patients who have undergone lung resection.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
China27 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 Guangzhou 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
Lingwei Wang, 15914030269
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
Min Zhang, 13823184488
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 Chronic Obstructive Pulmonary Disease Exacerbation in Shenzhen by National Respiratory Diseases Clinical Medicine Research Center
A prospective, multi-center, observational clinical trail. Aim to evaluate the real incidence of chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.
Read the detailed description
- Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
- To explore the relationship between pertussis infection and COPD exacerbation.
- Conditions
- COPD Exacerbation, Pertussis
- Being tested
- Blood sample, Data collection, Throat swab
- Medical subject headings
- Whooping 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 collectionOther
- 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;
- Assess COPD using ABCD assessment tool.
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 |
|---|---|---|
| Severe exacerbation of COPD | N = 250 Receives: Procedure: Blood sample; Other: Data collection; Procedure: Throat swab | |
| Mild and moderate exacerbations of COPD | N = 250 Receives: Procedure: Blood sample; Other: 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 COPD
According to the positive rate of bordetella pertussis nucleic acid, evaluate the prevalence of pertussis in COPD.
Measured: Day 0 of each subject at the time of enrollment.
Evaluation of the correlation between pertussis and COPD exacerbation
Evaluate the correlation between pertussis infection and COPD exacerbation by pertussis positive rate and exacerbation degree.
Measured: Day 0 of each subject at the time of enrollment.
Secondary outcomes (3)
Evaluation of the seroprevalence of Bordetella pertussis in COPD
According to anti-pertussis (anti-PT) antibody levels, assess the overall seroprevalence of Bordetella pertussis in COPD.
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.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- NCT04694430
- Sponsor's protocol ID
- WLW-COPD-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
Publications
Manian P. Chronic obstructive pulmonary disease classification, phenotypes and risk assessment. J Thorac Dis. 2019 Sep;11(Suppl 14):S1761-S1766. doi: 10.21037/jtd.2019.05.10.
PubMed 31632753Santus P, Pecchiari M, Tursi F, Valenti V, Saad M, Radovanovic D. The Airways' Mechanical Stress in Lung Disease: Implications for COPD Pathophysiology and Treatment Evaluation. Can Respir J. 2019 Sep 5;2019:3546056. doi: 10.1155/2019/3546056. eCollection 2019.
PubMed 31583033Canepa M, Franssen FME, Olschewski H, Lainscak M, Bohm M, Tavazzi L, Rosenkranz S. Diagnostic and Therapeutic Gaps in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2019 Oct;7(10):823-833. doi: 10.1016/j.jchf.2019.05.009. Epub 2019 Sep 11.
PubMed 31521680Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
PubMed 23245604Wang M, Luo X, Xu S, Liu W, Ding F, Zhang X, Wang L, Liu J, Hu J, Wang W. Trends in smoking prevalence and implication for chronic diseases in China: serial national cross-sectional surveys from 2003 to 2013. Lancet Respir Med. 2019 Jan;7(1):35-45. doi: 10.1016/S2213-2600(18)30432-6. Epub 2018 Oct 25.
PubMed 30482646Jia JH, Guo Q, Wan CM. [Resurgence and vaccine strategies of pertussis]. Zhonghua Er Ke Za Zhi. 2020 Aug 2;58(8):686-689. doi: 10.3760/cma.j.cn112140-20200116-00036. Chinese.
PubMed 32842393Huang H, Zhu T, Gao C, Gao Z, Liu Y, Ding Y, Sun J, Guo L, Liu P, Chen D, Wang L, Wu S, Zhang Y. Epidemiological features of pertussis resurgence based on community populations with high vaccination coverage in China. Epidemiol Infect. 2015 Jul;143(9):1950-6. doi: 10.1017/S095026881400260X. Epub 2014 Oct 7.
PubMed 25286969Huang HT, Gao ZG, Liu Y, Sun J, Liu P, Wang LJ, Li Y, Zhang J, Zhang Y. [Epidemiology of pertussis in adults and related factors in Tianjin, 2005-2014]. Zhonghua Liu Xing Bing Xue Za Zhi. 2016 May;37(5):678-81. doi: 10.3760/cma.j.issn.0254-6450.2016.05.018. Chinese.
PubMed 27188361Wang Y, Xu C, Ren J, Zhao Y, Li Y, Wang L, Yao S. The long-term effects of meteorological parameters on pertussis infections in Chongqing, China, 2004-2018. Sci Rep. 2020 Oct 14;10(1):17235. doi: 10.1038/s41598-020-74363-8.
PubMed 33057239Wang H, Zheng Y, de Groot R, Yang Y, Diavatopoulos DA, Chen Y, de Jonge MI, Deng J. High prevalence of Bordetella pertussis in young hospitalized infants with acute respiratory infection in the south of China: age- and season-dependent effects. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.009. Epub 2020 Jan 23. No abstract available.
PubMed 31981637
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 Chronic Obstructive Pulmonary Disease Exacerbation in Shenzhen by National Respiratory Diseases Clinical Medicine Research Center
- ClinicalTrials.gov ID
- NCT04694430
- Acronym / sponsor ID
- WLW-COPD-Pertussis
- Conditions
- COPD Exacerbation, Pertussis
- 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 chronic obstructive pulmonary disease (COPD) pertussis and the impact of pertussis on COPD exacerbation.
Detailed description
- Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
- To explore the relationship between pertussis infection and COPD exacerbation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe exacerbation of COPD | – | Procedure: Blood sample, Other: Data collection, Procedure: Throat swabN = 250 |
| Mild and moderate exacerbations of COPD | – | Procedure: Blood sample, Other: Data collection, Procedure: Throat swabN = 250 |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute COPD in Shenzhen
Key inclusion criteria (1 listed)
- Clinical diagnosis of acute COPD
Key exclusion criteria (1 listed)
- Major diseases except COPD; Significant abnormality in laboratory examination; Clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis or other simple restrictive ventilation dysfunction; Patients with a history of asthma, allergic rhinitis, or a blood eosinophil count of 2600/mm3 (0.6x10^9/L) within 4 weeks; Currently suffering from active tuberculosis; Patients with life-threatening pulmonary embolism, or al-antitrypsin deficiency, or cystic fibrosis; 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 | Mild and moderate exacerbations of COPD, Severe exacerbation of COPD |
| 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; 3. Assess COPD using ABCD assessment tool. | Other | Mild and moderate exacerbations of COPD, Severe exacerbation of COPD |
| 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 | Mild and moderate exacerbations of COPD, Severe exacerbation of COPD |
Primary outcome
Evaluation of the prevalence of pertussis among COPD
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 COPD.
Evaluation of the correlation between pertussis and COPD exacerbation
Time frame: Day 0 of each subject at the time of enrollment.
Evaluate the correlation between pertussis infection and COPD exacerbation by pertussis positive rate and exacerbation degree.
3 secondary outcomes
Evaluation of the seroprevalence of Bordetella pertussis in COPD
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.
- Background: PubMed 31632753Manian P. Chronic obstructive pulmonary disease classification, phenotypes and risk assessment. J Thorac Dis. 2019 Sep;11(Suppl 14):S1761-S1766. doi: 10.21037/jtd.2019.05.10.
- Background: PubMed 31583033Santus P, Pecchiari M, Tursi F, Valenti V, Saad M, Radovanovic D. The Airways' Mechanical Stress in Lung Disease: Implications for COPD Pathophysiology and Treatment Evaluation. Can Respir J. 2019 Sep 5;2019:3546056. doi: 10.1155/2019/3546056. eCollection 2019.
- Background: PubMed 31521680Canepa M, Franssen FME, Olschewski H, Lainscak M, Bohm M, Tavazzi L, Rosenkranz S. Diagnostic and Therapeutic Gaps in Patients With Heart Failure and Chronic Obstructive Pulmonary Disease. JACC Heart Fail. 2019 Oct;7(10):823-833. doi: 10.1016/j.jchf.2019.05.009. Epub 2019 Sep 11.
- Background: PubMed 23245604Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0.
- Background: PubMed 30482646Wang M, Luo X, Xu S, Liu W, Ding F, Zhang X, Wang L, Liu J, Hu J, Wang W. Trends in smoking prevalence and implication for chronic diseases in China: serial national cross-sectional surveys from 2003 to 2013. Lancet Respir Med. 2019 Jan;7(1):35-45. doi: 10.1016/S2213-2600(18)30432-6. Epub 2018 Oct 25.
- Background: PubMed 32842393Jia JH, Guo Q, Wan CM. [Resurgence and vaccine strategies of pertussis]. Zhonghua Er Ke Za Zhi. 2020 Aug 2;58(8):686-689. doi: 10.3760/cma.j.cn112140-20200116-00036. Chinese.
- Background: PubMed 25286969Huang H, Zhu T, Gao C, Gao Z, Liu Y, Ding Y, Sun J, Guo L, Liu P, Chen D, Wang L, Wu S, Zhang Y. Epidemiological features of pertussis resurgence based on community populations with high vaccination coverage in China. Epidemiol Infect. 2015 Jul;143(9):1950-6. doi: 10.1017/S095026881400260X. Epub 2014 Oct 7.
- Background: PubMed 27188361Huang HT, Gao ZG, Liu Y, Sun J, Liu P, Wang LJ, Li Y, Zhang J, Zhang Y. [Epidemiology of pertussis in adults and related factors in Tianjin, 2005-2014]. Zhonghua Liu Xing Bing Xue Za Zhi. 2016 May;37(5):678-81. doi: 10.3760/cma.j.issn.0254-6450.2016.05.018. Chinese.
- Background: PubMed 33057239Wang Y, Xu C, Ren J, Zhao Y, Li Y, Wang L, Yao S. The long-term effects of meteorological parameters on pertussis infections in Chongqing, China, 2004-2018. Sci Rep. 2020 Oct 14;10(1):17235. doi: 10.1038/s41598-020-74363-8.
- Background: PubMed 31981637Wang H, Zheng Y, de Groot R, Yang Y, Diavatopoulos DA, Chen Y, de Jonge MI, Deng J. High prevalence of Bordetella pertussis in young hospitalized infants with acute respiratory infection in the south of China: age- and season-dependent effects. J Infect. 2020 May;80(5):578-606. doi: 10.1016/j.jinf.2020.01.009. Epub 2020 Jan 23. No abstract available.
- 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
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation and Pertussis, run by Shenzhen People's Hospital at 27 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 27 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 COPD (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?
On the ClinicalTrials.gov record for NCT04694430, which also lists 10 linked publications.
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.