Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
NCT ID: NCT06286007
Last Updated: 2024-03-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
784 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-12-21
Study Completion Date
2026-07-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Impact of Bacterial Expression and Immune Response in the Severity of Pertussis
NCT05897879
Bordetella Pertussis, Whooping Cough
RECRUITING
NA
A Study to Determine the Epidemiology and Evaluate the Burden of Disease in Respiratory Syncytial Virus/Human Metapneumovirus and Influenza A Infected Hospitalized Participants (Adults and Children)
NCT03574532
Respiratory Tract Infections
COMPLETED
Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain.
NCT02838407
Infections, Streptococcal
COMPLETED
NA
RESCEU Study: Defining the Burden of Disease of Respiratory Syncytial Virus in Europe in Infants
NCT03627572
RSV Infection
Respiratory Syncytial Virus Infections
RSV Bronchiolitis
UNKNOWN
Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic
NCT06349707
Viral Pneumonia
COMPLETED
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The main objective is to estimate the annual symptomatic incidence of Bordetella pertussis and RSV infections in patients aged 18 years and over with asthma, which will be identified by PCR, for Bordetella pertussis and by PCR for RSV performed at a specific timepoint from onset of symptoms for each symptomatic Acute Respiratory Infection (ARI).
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
Depending on the symptoms presented and date of symptom onset, For pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.
A multicentre prospective cohort study will be undertaken in Spain. Thirty-five centres from different autonomous communities in Spain will participate in the study.
Participants will be asked to report to the investigator if they experience an asthma exacerbation or symptoms of acute respiratory infection with 2 years follow up
Depending on the symptoms presented and date of symptom onset, For pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Asthma
Pertussis
RSV Infection
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PCR
Depending on the symptoms presented and date of symptom onset, for pertussis, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 3 weeks For RSV, patients will undergo a nasopharyngeal swab specimen for PCR if onset of the symptoms was within the past 72 hours.
Intervention Type
DIAGNOSTIC_TEST
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Serology
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Adult patient (age 18 years and over)
* Diagnosed with asthma at least one year prior to the date of enrolment.
* Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and/or ARI symptoms occurring)
* Patients who are able to provide written informed consent.
* Diagnosed with asthma at least one year prior to the date of enrolment.
* Patients who, in the opinion of the investigator, can and will comply with the requirements of the study protocol for the duration of the follow-up period (e.g. agree to provide samples for testing, able to attend for testing upon asthma exacerbation and/or ARI symptoms occurring)
* Patients who are able to provide written informed consent.
Exclusion Criteria
* Patients with a prior history of pertussis in the last 12 months
* Patients with ARI within the 2 weeks prior to enrolment
* Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women.
* Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded.
* Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis).
* Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded.
* Patients who plan to move during the study period will be excluded.
* Patients with ARI within the 2 weeks prior to enrolment
* Patients who have another respiratory disease other than asthma, alcohol or drug abuse at the time of being included in the study, or an active oncological disease (patients in treatment or follow-up for oncological disease) or pregnant women.
* Patients treated with immunosuppressive or immunomodulating agents not related to asthma diagnosis. will be excluded.
* Patients vaccinated for RSV will be also excluded (NOTE: -Patients that have received an RSV (investigational) vaccine or medicine for any of the above, should be excluded from the study from the beginning. Patients that might be vaccinated in the upcoming years, while the study is still ongoing, can enrol. However, from the moment they receive a vaccine, they should be excluded and no additional data will be collected. Data collected during the study up until the time of vaccination will still be included in the analysis).
* Patients vaccinated for B. Pertussis during the previous 12 months will be also excluded.
* Patients who plan to move during the study period will be excluded.
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Translational Research In Airway Diseases Group (TRIAD)
UNKNOWN
Sponsor Role
collaborator
CIBER of Respiratory Diseases CIBERES
UNKNOWN
Sponsor Role
collaborator
Complexo Hospitalario Universitario de A Coruña
OTHER
Sponsor Role
collaborator
Hospital de Galdakao
OTHER
Sponsor Role
collaborator
Hospital Universitario Doctor Peset
OTHER
Sponsor Role
collaborator
Hospital San Pedro de Alcantara
OTHER
Sponsor Role
collaborator
Hospital Universitario Marqués de Valdecilla
OTHER
Sponsor Role
collaborator
Hospital Universitario Vall d´Hebron
UNKNOWN
Sponsor Role
collaborator
Universitat Autonoma de Barcelona
OTHER
Sponsor Role
collaborator
Universidade de Santiago de Compostela
UNKNOWN
Sponsor Role
collaborator
Consortium for Biomedical Research in Epidemiology and Public Health
UNKNOWN
Sponsor Role
collaborator
Hospital Universitario Virgen del Rocio
UNKNOWN
Sponsor Role
collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
OTHER
Sponsor Role
collaborator
University Hospital Virgen de las Nieves
OTHER
Sponsor Role
collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
OTHER
Sponsor Role
collaborator
Germans Trias i Pujol Hospital
OTHER
Sponsor Role
collaborator
Hospital of Navarra
OTHER
Sponsor Role
collaborator
Hospital Universitario de Jerez de la Frontera
UNKNOWN
Sponsor Role
collaborator
Hospital El Bierzo
OTHER
Sponsor Role
collaborator
Hospital Clinico Universitario San Cecilio
OTHER
Sponsor Role
collaborator
Hospital Donostia
OTHER
Sponsor Role
collaborator
Hospital Universitario Central de Asturias
OTHER
Sponsor Role
collaborator
Hospital Universitario de la Ribera
UNKNOWN
Sponsor Role
collaborator
Hospital Costa del Sol
OTHER
Sponsor Role
collaborator
Hospital General Universitario Dr. Balmis
UNKNOWN
Sponsor Role
collaborator
Hospital de Sagunto
OTHER
Sponsor Role
collaborator
Hospital Lluis Alcanyís de Xàtiva
UNKNOWN
Sponsor Role
collaborator
Hospital Universitario Lucus Augusti
OTHER
Sponsor Role
collaborator
Hospital del Mar
OTHER
Sponsor Role
collaborator
Hospital Universitario Virgen de la Arrixaca
OTHER
Sponsor Role
collaborator
Hospital Clinic of Barcelona
OTHER
Sponsor Role
collaborator
Hospital Clinico Universitario de Santiago
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francisco Javier González Barcala
Respiratory Medicine Specialist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Spain
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Guiso N, Gallais JL, Gavazzi G, Pinquier D, Gaillat J. Incidence of pertussis in subjects aged 50years and older in France in 2013-2014. Med Mal Infect. 2018 Feb;48(1):30-36. doi: 10.1016/j.medmal.2017.09.002. Epub 2017 Oct 13.
Reference Type
BACKGROUND
Weinberger R, Riffelmann M, Kennerknecht N, Hulsse C, Littmann M, O'Brien J, von Kries R, von Konig CHW. Long-lasting cough in an adult German population: incidence, symptoms, and related pathogens. Eur J Clin Microbiol Infect Dis. 2018 Apr;37(4):665-672. doi: 10.1007/s10096-017-3158-6. Epub 2018 Jan 4.
Reference Type
BACKGROUND
Leong RNF, Wood JG, Liu B, McIntyre PB, Newall AT. High healthcare resource utilisation due to pertussis in Australian adults aged 65 years and over. Vaccine. 2020 Apr 23;38(19):3553-3559. doi: 10.1016/j.vaccine.2020.03.021. Epub 2020 Mar 24.
Reference Type
BACKGROUND
Mbayei SA, Faulkner A, Miner C, Edge K, Cruz V, Pena SA, Kudish K, Coleman J, Pradhan E, Thomas S, Martin S, Skoff TH. Severe Pertussis Infections in the United States, 2011-2015. Clin Infect Dis. 2019 Jul 2;69(2):218-226. doi: 10.1093/cid/ciy889.
Reference Type
BACKGROUND
Jenkins VA, Savic M, Kandeil W. Pertussis in high-risk groups: an overview of the past quarter-century. Hum Vaccin Immunother. 2020 Nov 1;16(11):2609-2617. doi: 10.1080/21645515.2020.1738168. Epub 2020 Apr 16.
Reference Type
BACKGROUND
Martinon-Torres F, Heininger U, Thomson A, Wirsing von Konig CH. Controlling pertussis: how can we do it? A focus on immunization. Expert Rev Vaccines. 2018 Apr;17(4):289-297. doi: 10.1080/14760584.2018.1445530. Epub 2018 Mar 12.
Reference Type
BACKGROUND
Martinón-Torres F. Expected and Unexpected Effects of Vaccination. In: Vesikari T, Van Damme P, editors. Pediatric Vaccines and Vaccinations, Cham (Switzerland): 2017, p. 3-13
Reference Type
BACKGROUND
Aris E, Harrington L, Bhavsar A, Simeone JC, Ramond A, Papi A, Vogelmeier CF, Meszaros K, Lambrelli D, Mukherjee P. Burden of Pertussis in COPD: A Retrospective Database Study in England. COPD. 2021 Apr;18(2):157-169. doi: 10.1080/15412555.2021.1899155. Epub 2021 Apr 19.
Reference Type
BACKGROUND
Randi BA, Sejas ONE, Miyaji KT, Infante V, Lara AN, Ibrahim KY, Lopes MH, Sartori AMC. A systematic review of adult tetanus-diphtheria-acellular (Tdap) coverage among healthcare workers. Vaccine. 2019 Feb 14;37(8):1030-1037. doi: 10.1016/j.vaccine.2018.12.046. Epub 2019 Jan 7.
Reference Type
BACKGROUND
Rubin K, Glazer S. The pertussis hypothesis: Bordetella pertussis colonization in the etiology of asthma and diseases of allergic sensitization. Med Hypotheses. 2018 Nov;120:101-115. doi: 10.1016/j.mehy.2018.08.006. Epub 2018 Aug 10.
Reference Type
BACKGROUND
Martini H, Rodeghiero C, VAN DEN Poel C, Vincent M, Pierard D, Huygen K. Pertussis diagnosis in Belgium: results of the National Reference Centre for Bordetella anno 2015. Epidemiol Infect. 2017 Aug;145(11):2366-2373. doi: 10.1017/S0950268817001108. Epub 2017 Jun 5.
Reference Type
BACKGROUND
Marchi S, Montomoli E, Remarque EJ, Monteverde Spencer GT, Azzarello A, Viviani S, Trombetta CM. Pertussis over two decades: seroepidemiological study in a large population of the Siena Province, Tuscany Region, Central Italy. BMJ Open. 2019 Oct 30;9(10):e032987. doi: 10.1136/bmjopen-2019-032987.
Reference Type
BACKGROUND
Brugueras S, Rius C, Millet JP, Casals M, Cayla JA; Barcelona Pertussis Working Group. Does the economic recession influence the incidence of pertussis in a cosmopolitan European city? BMC Public Health. 2019 Feb 4;19(1):144. doi: 10.1186/s12889-019-6448-3.
Reference Type
BACKGROUND
Langsam D, Anis E, Haas EJ, Gosinov R, Yechezkel M, Grotto I, Shmueli E, Yamin D. Tdap vaccination during pregnancy interrupts a twenty-year increase in the incidence of pertussis. Vaccine. 2020 Mar 10;38(12):2700-2706. doi: 10.1016/j.vaccine.2020.01.095. Epub 2020 Feb 15.
Reference Type
BACKGROUND
Abu-Raya B, Maertens K, Edwards KM, Omer SB, Englund JA, Flanagan KL, Snape MD, Amirthalingam G, Leuridan E, Damme PV, Papaevangelou V, Launay O, Dagan R, Campins M, Cavaliere AF, Frusca T, Guidi S, O'Ryan M, Heininger U, Tan T, Alsuwaidi AR, Safadi MA, Vilca LM, Wanlapakorn N, Madhi SA, Giles ML, Prymula R, Ladhani S, Martinon-Torres F, Tan L, Michelin L, Scambia G, Principi N, Esposito S. Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement. Front Immunol. 2020 Jun 24;11:1282. doi: 10.3389/fimmu.2020.01282. eCollection 2020.
Reference Type
BACKGROUND
Campins M, Moreno-Perez D, Gil-de Miguel A, Gonzalez-Romo F, Moraga-Llop FA, Aristegui-Fernandez J, Gonce-Mellgren A, Bayas JM, Salleras-Sanmarti L. [Whooping cough in Spain. Current epidemiology, prevention and control strategies. Recommendations by the Pertussis Working Group]. Enferm Infecc Microbiol Clin. 2013 Apr;31(4):240-53. doi: 10.1016/j.eimc.2012.12.011. Epub 2013 Feb 12. Spanish.
Reference Type
BACKGROUND
Redondo E, Rivero-Calle I, Mascaros E, Yuste JE, Fernandez-Prada M, Ocana D, Jimeno I, Gil A, Molina J, Diaz-Maroto JL, Linares M, Martinon-Torres F; en nombre de Neumoexpertos en Prevencion. [Vaccination against community acquired pneumonia in adults. Update 2021 of the position paper by Neumoexpertos en Prevencion Group]. Semergen. 2021 Sep;47(6):411-425. doi: 10.1016/j.semerg.2021.06.005. Epub 2021 Jul 29. Spanish.
Reference Type
BACKGROUND
Kandeil W, Atanasov P, Avramioti D, Fu J, Demarteau N, Li X. The burden of pertussis in older adults: what is the role of vaccination? A systematic literature review. Expert Rev Vaccines. 2019 May;18(5):439-455. doi: 10.1080/14760584.2019.1588727. Epub 2019 Mar 25.
Reference Type
BACKGROUND
Miyashita N, Akaike H, Teranishi H, Kawai Y, Ouchi K, Kato T, Hayashi T, Okimoto N. Diagnostic value of symptoms and laboratory data for pertussis in adolescent and adult patients. BMC Infect Dis. 2013 Mar 11;13:129. doi: 10.1186/1471-2334-13-129.
Reference Type
BACKGROUND
Schlaud M, Schmitz R, Poethko-Muller C, Kuhnert R. Vaccinations in the first year of life and risk of atopic disease - Results from the KiGGS study. Vaccine. 2017 Sep 12;35(38):5156-5162. doi: 10.1016/j.vaccine.2017.07.111. Epub 2017 Aug 8.
Reference Type
BACKGROUND
McDonald KL, Huq SI, Lix LM, Becker AB, Kozyrskyj AL. Delay in diphtheria, pertussis, tetanus vaccination is associated with a reduced risk of childhood asthma. J Allergy Clin Immunol. 2008 Mar;121(3):626-31. doi: 10.1016/j.jaci.2007.11.034. Epub 2008 Jan 18.
Reference Type
BACKGROUND
Vogt H, Braback L, Kling AM, Grunewald M, Nilsson L. Pertussis immunization in infancy and adolescent asthma medication. Pediatrics. 2014 Oct;134(4):721-8. doi: 10.1542/peds.2014-0723. Epub 2014 Sep 22.
Reference Type
BACKGROUND
Nagel G, Weinmayr G, Flohr C, Kleiner A, Strachan DP; ISAAC Phase Two Study Group. Association of pertussis and measles infections and immunizations with asthma and allergic sensitization in ISAAC Phase Two. Pediatr Allergy Immunol. 2012 Dec;23(8):737-46. doi: 10.1111/pai.12007. Epub 2012 Sep 24.
Reference Type
BACKGROUND
McKeever TM, Lewis SA, Smith C, Hubbard R. Vaccination and allergic disease: a birth cohort study. Am J Public Health. 2004 Jun;94(6):985-9. doi: 10.2105/ajph.94.6.985.
Reference Type
BACKGROUND
Buck PO, Meyers JL, Gordon LD, Parikh R, Kurosky SK, Davis KL. Economic burden of diagnosed pertussis among individuals with asthma or chronic obstructive pulmonary disease in the USA: an analysis of administrative claims. Epidemiol Infect. 2017 Jul;145(10):2109-2121. doi: 10.1017/S0950268817000887. Epub 2017 May 2.
Reference Type
BACKGROUND
Capili CR, Hettinger A, Rigelman-Hedberg N, Fink L, Boyce T, Lahr B, Juhn YJ. Increased risk of pertussis in patients with asthma. J Allergy Clin Immunol. 2012 Apr;129(4):957-63. doi: 10.1016/j.jaci.2011.11.020. Epub 2011 Dec 28.
Reference Type
BACKGROUND
Liu BC, McIntyre P, Kaldor JM, Quinn HE, Ridda I, Banks E. Pertussis in older adults: prospective study of risk factors and morbidity. Clin Infect Dis. 2012 Dec;55(11):1450-6. doi: 10.1093/cid/cis627. Epub 2012 Jul 17.
Reference Type
BACKGROUND
Harju TH, Leinonen M, Nokso-Koivisto J, Korhonen T, Raty R, He Q, Hovi T, Mertsola J, Bloigu A, Rytila P, Saikku P. Pathogenic bacteria and viruses in induced sputum or pharyngeal secretions of adults with stable asthma. Thorax. 2006 Jul;61(7):579-84. doi: 10.1136/thx.2005.056291. Epub 2006 Mar 3.
Reference Type
BACKGROUND
De Serres G, Shadmani R, Duval B, Boulianne N, Dery P, Douville Fradet M, Rochette L, Halperin SA. Morbidity of pertussis in adolescents and adults. J Infect Dis. 2000 Jul;182(1):174-9. doi: 10.1086/315648. Epub 2000 Jun 30.
Reference Type
BACKGROUND
Ristic M, Radosavljevic B, Stojanovic VD, Dilas M, Petrovic V. Performance of the new clinical case definitions of pertussis in pertussis suspected infection and other diagnoses similar to pertussis. PLoS One. 2018 Sep 20;13(9):e0204103. doi: 10.1371/journal.pone.0204103. eCollection 2018.
Reference Type
BACKGROUND
Wilkinson TMA, Van den Steen P, Cheuvart B, Baudson N, Dodet M, Turriani E, Harrington L, Meyer N, Rondini S, Taddei L, Mukherjee P. Seroprevalence of Bordetella pertussis Infection in Patients With Chronic Obstructive Pulmonary Disease in England: Analysis of the AERIS Cohort. COPD. 2021 Jun;18(3):341-348. doi: 10.1080/15412555.2021.1920904. Epub 2021 May 6.
Reference Type
BACKGROUND
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.
Reference Type
BACKGROUND
Walsh EE. Respiratory Syncytial Virus Infection: An Illness for All Ages. Clin Chest Med. 2017 Mar;38(1):29-36. doi: 10.1016/j.ccm.2016.11.010. Epub 2016 Dec 27.
Reference Type
BACKGROUND
Matsumoto K, Inoue H. Viral infections in asthma and COPD. Respir Investig. 2014 Mar;52(2):92-100. doi: 10.1016/j.resinv.2013.08.005. Epub 2013 Sep 27.
Reference Type
BACKGROUND
Fleming DM, Taylor RJ, Lustig RL, Schuck-Paim C, Haguinet F, Webb DJ, Logie J, Matias G, Taylor S. Modelling estimates of the burden of Respiratory Syncytial virus infection in adults and the elderly in the United Kingdom. BMC Infect Dis. 2015 Oct 23;15:443. doi: 10.1186/s12879-015-1218-z.
Reference Type
BACKGROUND
Westerly BD, Peebles RS Jr. Respiratory syncytial virus infections in the adult asthmatic--mechanisms of host susceptibility and viral subversion. Immunol Allergy Clin North Am. 2010 Nov;30(4):523-39, vi-vii. doi: 10.1016/j.iac.2010.08.006. Epub 2010 Sep 22.
Reference Type
BACKGROUND
Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE. Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med. 2005 Apr 28;352(17):1749-59. doi: 10.1056/NEJMoa043951.
Reference Type
BACKGROUND
Falsey AR, Walsh EE, Capellan J, Gravenstein S, Zambon M, Yau E, Gorse GJ, Edelman R, Hayden FG, McElhaney JE, Neuzil KM, Nichol KL, Simoes EA, Wright PF, Sales VM. Comparison of the safety and immunogenicity of 2 respiratory syncytial virus (rsv) vaccines--nonadjuvanted vaccine or vaccine adjuvanted with alum--given concomitantly with influenza vaccine to high-risk elderly individuals. J Infect Dis. 2008 Nov 1;198(9):1317-26. doi: 10.1086/592168.
Reference Type
BACKGROUND
Widmer K, Griffin MR, Zhu Y, Williams JV, Talbot HK. Respiratory syncytial virus- and human metapneumovirus-associated emergency department and hospital burden in adults. Influenza Other Respir Viruses. 2014 May;8(3):347-52. doi: 10.1111/irv.12234. Epub 2014 Feb 7.
Reference Type
BACKGROUND
Lee N, Lui GC, Wong KT, Li TC, Tse EC, Chan JY, Yu J, Wong SS, Choi KW, Wong RY, Ngai KL, Hui DS, Chan PK. High morbidity and mortality in adults hospitalized for respiratory syncytial virus infections. Clin Infect Dis. 2013 Oct;57(8):1069-77. doi: 10.1093/cid/cit471. Epub 2013 Jul 21.
Reference Type
BACKGROUND
Zambon MC, Stockton JD, Clewley JP, Fleming DM. Contribution of influenza and respiratory syncytial virus to community cases of influenza-like illness: an observational study. Lancet. 2001 Oct 27;358(9291):1410-6. doi: 10.1016/s0140-6736(01)06528-x.
Reference Type
BACKGROUND
Sundaram ME, Meece JK, Sifakis F, Gasser RA Jr, Belongia EA. Medically attended respiratory syncytial virus infections in adults aged >/= 50 years: clinical characteristics and outcomes. Clin Infect Dis. 2014 Feb;58(3):342-9. doi: 10.1093/cid/cit767. Epub 2013 Nov 21.
Reference Type
BACKGROUND
Griffin MR, Coffey CS, Neuzil KM, Mitchel EF Jr, Wright PF, Edwards KM. Winter viruses: influenza- and respiratory syncytial virus-related morbidity in chronic lung disease. Arch Intern Med. 2002 Jun 10;162(11):1229-36. doi: 10.1001/archinte.162.11.1229.
Reference Type
BACKGROUND
Bianchini S, Silvestri E, Argentiero A, Fainardi V, Pisi G, Esposito S. Role of Respiratory Syncytial Virus in Pediatric Pneumonia. Microorganisms. 2020 Dec 21;8(12):2048. doi: 10.3390/microorganisms8122048.
Reference Type
BACKGROUND
Pneumonia Etiology Research for Child Health (PERCH) Study Group. Causes of severe pneumonia requiring hospital admission in children without HIV infection from Africa and Asia: the PERCH multi-country case-control study. Lancet. 2019 Aug 31;394(10200):757-779. doi: 10.1016/S0140-6736(19)30721-4. Epub 2019 Jun 27.
Reference Type
BACKGROUND
Loubet P, Voiriot G, Houhou-Fidouh N, Neuville M, Bouadma L, Lescure FX, Descamps D, Timsit JF, Yazdanpanah Y, Visseaux B. Impact of respiratory viruses in hospital-acquired pneumonia in the intensive care unit: A single-center retrospective study. J Clin Virol. 2017 Jun;91:52-57. doi: 10.1016/j.jcv.2017.04.001. Epub 2017 Apr 22.
Reference Type
BACKGROUND
Feddema JJ, Claassen E. Prevalence of viral respiratory infections amongst asthmatics: Results of a meta-regression analysis. Respir Med. 2020 Nov;173:106020. doi: 10.1016/j.rmed.2020.106020. Epub 2020 May 15.
Reference Type
BACKGROUND
Cilloniz C, Pericas JM, Rojas JR, Torres A. Severe Infections Due to Respiratory Viruses. Semin Respir Crit Care Med. 2022 Feb;43(1):60-74. doi: 10.1055/s-0041-1740982. Epub 2022 Feb 16.
Reference Type
BACKGROUND
Luyt CE. Virus diseases in ICU patients: a long time underestimated; but be aware of overestimation. Intensive Care Med. 2006 Jul;32(7):968-70. doi: 10.1007/s00134-006-0203-9. Epub 2006 May 24. No abstract available.
Reference Type
BACKGROUND
Sigurs N, Gustafsson PM, Bjarnason R, Lundberg F, Schmidt S, Sigurbergsson F, Kjellman B. Severe respiratory syncytial virus bronchiolitis in infancy and asthma and allergy at age 13. Am J Respir Crit Care Med. 2005 Jan 15;171(2):137-41. doi: 10.1164/rccm.200406-730OC. Epub 2004 Oct 29.
Reference Type
BACKGROUND
Stein RT, Sherrill D, Morgan WJ, Holberg CJ, Halonen M, Taussig LM, Wright AL, Martinez FD. Respiratory syncytial virus in early life and risk of wheeze and allergy by age 13 years. Lancet. 1999 Aug 14;354(9178):541-5. doi: 10.1016/S0140-6736(98)10321-5.
Reference Type
BACKGROUND
Beasley R, Coleman ED, Hermon Y, Holst PE, O'Donnell TV, Tobias M. Viral respiratory tract infection and exacerbations of asthma in adult patients. Thorax. 1988 Sep;43(9):679-83. doi: 10.1136/thx.43.9.679.
Reference Type
BACKGROUND
Gehlhar K, Bilitewski C, Reinitz-Rademacher K, Rohde G, Bufe A. Impaired virus-induced interferon-alpha2 release in adult asthmatic patients. Clin Exp Allergy. 2006 Mar;36(3):331-7. doi: 10.1111/j.1365-2222.2006.02450.x.
Reference Type
BACKGROUND
Grissell TV, Powell H, Shafren DR, Boyle MJ, Hensley MJ, Jones PD, Whitehead BF, Gibson PG. Interleukin-10 gene expression in acute virus-induced asthma. Am J Respir Crit Care Med. 2005 Aug 15;172(4):433-9. doi: 10.1164/rccm.200412-1621OC. Epub 2005 May 13.
Reference Type
BACKGROUND
van Scott MR, Justice JP, Bradfield JF, Enright E, Sigounas A, Sur S. IL-10 reduces Th2 cytokine production and eosinophilia but augments airway reactivity in allergic mice. Am J Physiol Lung Cell Mol Physiol. 2000 Apr;278(4):L667-74. doi: 10.1152/ajplung.2000.278.4.L667.
Reference Type
BACKGROUND
Hancock GE, Scheuer CA, Sierzega R, Pryharski KS, McBride JT, Watelet LF, Tebbey PW, Smith JD. Adaptive immune responses of patients with asthma to the attachment (G) glycoprotein of respiratory synctial virus. J Infect Dis. 2001 Dec 15;184(12):1589-93. doi: 10.1086/324583.
Reference Type
BACKGROUND
O'Sullivan S, Cormican L, Faul JL, Ichinohe S, Johnston SL, Burke CM, Poulter LW. Activated, cytotoxic CD8(+) T lymphocytes contribute to the pathology of asthma death. Am J Respir Crit Care Med. 2001 Aug 15;164(4):560-4. doi: 10.1164/ajrccm.164.4.2102018.
Reference Type
BACKGROUND
Coyle AJ, Erard F, Bertrand C, Walti S, Pircher H, Le Gros G. Virus-specific CD8+ cells can switch to interleukin 5 production and induce airway eosinophilia. J Exp Med. 1995 Mar 1;181(3):1229-33. doi: 10.1084/jem.181.3.1229.
Reference Type
BACKGROUND
Bjornsson E, Hjelm E, Janson C, Fridell E, Boman G. Serology of respiratory viruses in relation to asthma and bronchial hyperresponsiveness. Ups J Med Sci. 1996;101(2):159-68. doi: 10.3109/03009739609178920.
Reference Type
BACKGROUND
Douville RN, Bastien N, Li Y, Simons FE, HayGlass KT. Adult asthmatics display exaggerated IFNgamma responses to human metapneumovirus and respiratory syncytial virus. Biochem Cell Biol. 2007 Apr;85(2):252-8. doi: 10.1139/O07-005.
Reference Type
BACKGROUND
Hirose H, Matsuse H, Tsuchida T, Fukahori S, Fukushima C, Mizuta Y, Kohno S. Cytokine production from peripheral blood mononuclear cells of mite allergen-sensitized atopic adults stimulated with respiratory syncytial virus and mite allergen. Int Arch Allergy Immunol. 2008;146(2):149-55. doi: 10.1159/000113518. Epub 2008 Jan 18.
Reference Type
BACKGROUND
Lukacs NW, Tekkanat KK, Berlin A, Hogaboam CM, Miller A, Evanoff H, Lincoln P, Maassab H. Respiratory syncytial virus predisposes mice to augmented allergic airway responses via IL-13-mediated mechanisms. J Immunol. 2001 Jul 15;167(2):1060-5. doi: 10.4049/jimmunol.167.2.1060.
Reference Type
BACKGROUND
Johnson TR, Parker RA, Johnson JE, Graham BS. IL-13 is sufficient for respiratory syncytial virus G glycoprotein-induced eosinophilia after respiratory syncytial virus challenge. J Immunol. 2003 Feb 15;170(4):2037-45. doi: 10.4049/jimmunol.170.4.2037.
Reference Type
BACKGROUND
McLaughlin JM, Khan F, Begier E, Swerdlow DL, Jodar L, Falsey AR. Rates of Medically Attended RSV Among US Adults: A Systematic Review and Meta-analysis. Open Forum Infect Dis. 2022 Jun 17;9(7):ofac300. doi: 10.1093/ofid/ofac300. eCollection 2022 Jul.
Reference Type
BACKGROUND
Zhang Y, Sakthivel SK, Bramley A, Jain S, Haynes A, Chappell JD, Hymas W, Lenny N, Patel A, Qi C, Ampofo K, Arnold SR, Self WH, Williams DJ, Hillyard D, Anderson EJ, Grijalva CG, Zhu Y, Wunderink RG, Edwards KM, Pavia AT, McCullers JA, Erdman DD. Serology Enhances Molecular Diagnosis of Respiratory Virus Infections Other than Influenza in Children and Adults Hospitalized with Community-Acquired Pneumonia. J Clin Microbiol. 2016 Dec 28;55(1):79-89. doi: 10.1128/JCM.01701-16. Print 2017 Jan.
Reference Type
BACKGROUND
Vega JM, Badia X, Badiola C, Lopez-Vina A, Olaguibel JM, Picado C, Sastre J, Dal-Re R; Covalair Investigator Group. Validation of the Spanish version of the Asthma Control Test (ACT). J Asthma. 2007 Dec;44(10):867-72. doi: 10.1080/02770900701752615.
Reference Type
BACKGROUND
Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
Reference Type
BACKGROUND
Dafauce L, Romero D, Carpio C, Barga P, Quirce S, Villasante C, Bravo MF, Alvarez-Sala R. Psycho-demographic profile in severe asthma and effect of emotional mood disorders and hyperventilation syndrome on quality of life. BMC Psychol. 2021 Jan 6;9(1):3. doi: 10.1186/s40359-020-00498-y.
Reference Type
BACKGROUND
Galan I, Rodriguez-Artalejo F, Tobias A, Diez-Ganan L, Gandarillas A, Zorrilla B. Clustering of behavior-related risk factors and its association with subjective health. Gac Sanit. 2005 Sep-Oct;19(5):370-8. doi: 10.1157/13080135.
Reference Type
BACKGROUND
Zeevat F, Luttjeboer J, Paulissen JHJ, van der Schans J, Beutels P, Boersma C, Postma MJ; RESCEU Investigators. Exploratory Analysis of the Economically Justifiable Price of a Hypothetical RSV Vaccine for Older Adults in the Netherlands and the United Kingdom. J Infect Dis. 2022 Aug 12;226(Suppl 1):S102-S109. doi: 10.1093/infdis/jiab118.
Reference Type
BACKGROUND
Falsey AR, Walsh EE, Esser MT, Shoemaker K, Yu L, Griffin MP. Respiratory syncytial virus-associated illness in adults with advanced chronic obstructive pulmonary disease and/or congestive heart failure. J Med Virol. 2019 Jan;91(1):65-71. doi: 10.1002/jmv.25285. Epub 2018 Sep 24.
Reference Type
BACKGROUND
Related Links
Access external resources that provide additional context or updates about the study.
http://www.cdc.gov/vaccines/vpd/pertussis/
Access in June 2021
http://www.salute.gov.it/imgs/C_17_pubblicazioni_2571_allegato.pdf
Access in June 2021
http://www.fhi.no/sv/vaksine/voksenvaksinasjon/oversikt-anbefalte-vaksiner-for-voksne/
Access in June 2021
https://goldcopd.org/wp-content/uploads/2020/11/GOLD-REPORT-2021-v1.1-25Nov20_WMV.pdf
Access in June 2021
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRIPASCO-2023
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Seroepidemiological Study of Pertussis and Other Infectious Diseases
NCT01929473
COMPLETED
Early Identification and Severity Prediction of Acute Respiratory Infectious Disease
NCT04955756
UNKNOWN
NA
Infectious Pathogens in Acute Respiratory Illness in Adults and Elderly
NCT01360398
COMPLETED
NA
A Study of Acute Respiratory Infections in Global Outpatient Setting
NCT05148780
COMPLETED
EARLY_PHASE1
RSV Burden in Outpatient Settings
NCT04743609
UNKNOWN
RESCEU Study, Defining the Burden of Disease of RSV in Older Adults
NCT03621930
UNKNOWN
A Study in Belgian Children Hospitalized With Respiratory Syncytial Virus Related Acute Respiratory Infections
NCT02133092
COMPLETED
Audio Data Collection for Identification and Classification of Coughing
NCT04326309
COMPLETED
Hospital Stay and Respiratory Infection
NCT02047383
COMPLETED
Clinical and Prognostic Comparisons Between Invasive Pulmonary Aspergillosis With or Without Invasive Tracheobronchitis During Severe Influenza: a Retrospective Multicenter Cohort Study.
NCT04077697
COMPLETED
Use of MULTIplex PCR, Procalcitonin, and Sputum Appearance to Reduce Duration of Antibiotic Therapy During Severe COPD EXAcerbation: A Controlled, Randomized, Open-label, Parallel-Group, Multicenter Trial
NCT05280132
RECRUITING
NA
Study Evaluating the Impact of Using Triplex Rapid Diagnostic Tests (SARS-CoV-2/Influenza/RSV) on Antibiotic Prescribing
NCT07243249
RECRUITING
NA
Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.
NCT05765838
UNKNOWN
NA
Detecting Respiratory Viruses in Upper and Lower Respiratory Tract Samples
NCT01597089
TERMINATED
Respiratory Virus Infections in Acutely Hospitalized Adult Patients With Pulmonary and Extrapulmonary Complications
NCT03816059
UNKNOWN
Home Testing of Respiratory Illness
NCT04245800
COMPLETED
Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
NCT06161285
RECRUITING
To Evaluate Mucosal and Systematic Immune Response to Acute Respiratory Tract Infections of South African Children
NCT06902194
RECRUITING
Characterization of Respiratory Microbiota in Susceptibility to Viral Respiratory Infections
NCT03600753
UNKNOWN
NA
Pattern and Outcomes of Chest Diseases
NCT06053528
UNKNOWN
Biomarkers for the Prognosis of Influenza in Children
NCT03231995
COMPLETED
NA
Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
NCT05042063
COMPLETED
Digital Acoustic Surveillance for Early Detection of Respiratory Disease Outbreaks
NCT04762693
COMPLETED
Remote Assessment of Outpatient With Severe Acute Respiratory Syndrome (SARS-CoV-2)
NCT05125887
UNKNOWN
Clinical Trial for the Assessment of Delayed Antibiotic Treatment Strategies
NCT01363531
COMPLETED
PHASE4