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A Multi-center Study to Determine the Prevalence and Influence of Pertussis on COPD Exacerbation in Shenzhen

NCT04694430 — Unknown, 500 participants, Shenzhen People's Hospital

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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

RegistryNCT04694430
StatusUnknown
Study typeObservational
Enrollment500 (Estimated)
SponsorShenzhen People's Hospital (Other)
ConditionsCOPD Exacerbation, Pertussis
InterventionsBlood sample, Data collection, Throat swab (Procedure, other)
Datesstart 2021-01-01 (estimated), primary completion 2021-06-30 (estimated), completion 2021-12-31 (estimated), first posted 2021-01-05, last updated 2021-01-05
Locations27 sites in China

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-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.

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+Detailed description

1. Investigate the incidence and epidemiological characteristics of pertussis infection in COPD population.
2. To explore the relationship between pertussis infection and COPD exacerbation.

+Arms and interventions

ArmTypeInterventionsDescription
Severe exacerbation of COPDProcedure: Blood sample; Other: Data collection; Procedure: Throat swabN = 250
Mild and moderate exacerbations of COPDProcedure: Blood sample; Other: Data collection; Procedure: Throat swabN = 250
  • Blood sample (Procedure): 2 ml venous blood was collected and separated into serum.
  • Data collection (Other): 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; 3. Assess COPD using ABCD assessment tool.
  • Throat swab (Procedure): 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.

+Outcome measures

Primary outcomes

  • Evaluation of the prevalence of pertussis among COPD [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 [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.

Secondary outcomes

  • Evaluation of the seroprevalence of Bordetella pertussis in COPD [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 COPD.
  • 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.

+Eligibility

Sex: All, ages: 40 Years to 80 Years

Inclusion Criteria:

\- Clinical diagnosis of acute COPD

Exclusion Criteria:

\- 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.

+Locations (27)

FacilityCityCountryStatus
Fuyong people's Hospital of Baoan District, ShenzhenShenzhenChina
General Hospital of Shenzhen UniversityShenzhenChina
Longhua Branch of Shenzhen People's HospitalShenzhenChina
Nanshan District People's HospitalShenzhenChina
Peking university shenzhen hospitalShenzhenChina
Shenzhen Bao'an District Central HospitalShenzhenChina
Shenzhen Bao'an District People's HospitalShenzhenChina
Shenzhen Hospital of Beijing University of traditional Chinese MedicineShenzhenChina
Shenzhen Hospital of Guangzhou University of traditional Chinese MedicineShenzhenChina
Shenzhen Hospital of Southern Medical UniversityShenzhenChina
Shenzhen Hospital of the University of Hong KongShenzhenChina
Shenzhen Longgang District Central HospitalShenzhenChina
Shenzhen Longgang District People's HospitalShenzhenChina
Shenzhen Longgang District Second People's HospitalShenzhenChina
Shenzhen Longgang District Third People's HospitalShenzhenChina
Shenzhen Longhua District Central HospitalShenzhenChina
Shenzhen Longhua District People's HospitalShenzhenChina
Shenzhen Luohu District People's HospitalShenzhenChina
Shenzhen People's HospitalShenzhenChina
Shenzhen Pingshan District Hospital of traditional Chinese MedicineShenzhenChina
Shenzhen Pingshan District People's HospitalShenzhenChina
Shenzhen Qianhai Shekou Free Trade Zone HospitalShenzhenChina
Shenzhen Second People's HospitalShenzhenChina
Shenzhen TCM HospitalShenzhenChina
Shenzhen Yantian District People's HospitalShenzhenChina
South University of science and Technology HospitalShenzhenChina
The eighth Affiliated Hospital of Sun Yat sen UniversityShenzhenChina

+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. PMID 31632753
  • Santus 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. PMID 31583033
  • Canepa 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. PMID 31521680
  • Lozano 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. PMID 23245604
  • Wang 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. PMID 30482646
  • Jia 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. PMID 32842393
  • Huang 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. PMID 25286969
  • Huang 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. PMID 27188361
  • Wang 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. PMID 33057239
  • Wang 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. PMID 31981637

+Investigators

My Notes