AsthmaPRIPASCONCT06286007
Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
An observational study of Asthma and Pertussis, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma, Pertussis, RSV Infection
- What is being tested?
- PCR
- How many people
- 784 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2023to 1 Jul 2026
- How long will I take part?
- 2 Years
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients (18 years and over) with asthma diagnosed at least one year before will be enrolled from the asthma clinics of selected hospitals. Every group (at each participating site) should include 35% of patients over 60 years old considering that this age-group has higher risk of infection and worse prognosis than the younger one.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Francisco-Javier GONZALEZ BARCALA, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Clínico Universitario de Santiago de Compostela
Santiago de Compostela, A Coruña, 15706
Francisco Javier González Barcala, Ph.D., francisco.javier.gonzalez.barcala@sergas.es
About this study
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
Read the detailed description
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.
- Conditions
- Asthma, Pertussis, RSV Infection
- Being tested
- PCR
- Keywords
- Asthma, Pertussis, RSV Infection, Exacerbations
- Medical subject headings
- Asthma, Whooping Cough, Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCRDiagnostic test
Also called Serology
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test
Measured: 2 years
Secondary outcomes (3)
To describe the seroprevalence of Bordetella pertussis in adult patients with asthma
To describe the seroprevalence of Bordetella pertussis in adult patients aged with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test
Measured: 2 years
To describe the seroprevalence of RSV in adult patients with asthma
To describe the seroprevalence RSV in adult patients with asthma, at the time of inclusion, at 12 months, and at the end of two years follow-up, in all the patients that are still included in the study, using serological test
Measured: 2 years
To evaluate the severity and control of the asthma caused by either BP or RSV infection
To evaluate, on an annual basis, the severity and control of the asthma, with regards to acute laboratory-confirmed respiratory illness caused by either BP or RSV infection during the study, using Asthma Control Test (ACT) questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start21 Dec 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (71)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 784 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital Clinico Universitario de Santiago
- Sponsor type
- University, hospital or other
- Collaborators
- Translational Research In Airway Diseases Group (TRIAD), CIBER of Respiratory Diseases CIBERES, Complexo Hospitalario Universitario de A Coruña, Hospital de Galdakao, Hospital Universitario Doctor Peset, Hospital San Pedro de Alcantara, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Vall d´Hebron, Universitat Autonoma de Barcelona, Universidade de Santiago de Compostela, Consortium for Biomedical Research in Epidemiology and Public Health, Hospitales Universitarios Virgen del Rocío, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, University Hospital Virgen de las Nieves, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital of Navarra, Hospital Universitario de Jerez de la Frontera, Hospital El Bierzo, Hospital Clinico Universitario San Cecilio, Hospital Donostia, Hospital Universitario Central de Asturias, Hospital Universitario de la Ribera, Hospital Costa del Sol, Hospital General Universitario Dr. Balmis, Hospital de Sagunto, Hospital Lluis Alcanyís de Xàtiva, Hospital Universitario Lucus Augusti, Hospital del Mar, Hospital Universitario Virgen de la Arrixaca, Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Francisco Javier González Barcala, Hospital Clinico Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286007
- Sponsor's protocol ID
- PRIPASCO-2023
- Acronym
- PRIPASCO
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29037454Weinberger 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.
PubMed 29302815Leong 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.
PubMed 32220516Mbayei 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.
PubMed 30321305Jenkins 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.
PubMed 32298213Martinon-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.
PubMed 29482390Martinón-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
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.
PubMed 33866914Randi 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.
PubMed 30630694Rubin 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.
PubMed 30220328Martini 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.
PubMed 28578723Marchi 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.
PubMed 31666278Brugueras 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.
PubMed 30717741Langsam 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.
PubMed 32070682Abu-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.
PubMed 32670282
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Impact of Pertussis and RSV on Asthma Severity and Control
- ClinicalTrials.gov ID
- NCT06286007
- Acronym / sponsor ID
- PRIPASCO / PRIPASCO-2023
- Conditions
- Asthma, Pertussis, RSV Infection
- Keywords
- Asthma, Pertussis, RSV Infection, Exacerbations
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 784 participants (estimated)
- Lead sponsor
- Hospital Clinico Universitario de SantiagoUniversity, hospital or other
- Collaborators
- Translational Research In Airway Diseases Group (TRIAD), CIBER of Respiratory Diseases CIBERES, Complexo Hospitalario Universitario de A Coruña, Hospital de Galdakao, Hospital Universitario Doctor Peset, Hospital San Pedro de Alcantara, Hospital Universitario Marqués de Valdecilla, Hospital Universitario Vall d´Hebron, Universitat Autonoma de Barcelona, Universidade de Santiago de Compostela, Consortium for Biomedical Research in Epidemiology and Public Health, Hospitales Universitarios Virgen del Rocío, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, University Hospital Virgen de las Nieves, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau, Germans Trias i Pujol Hospital, Hospital of Navarra, Hospital Universitario de Jerez de la Frontera, Hospital El Bierzo, Hospital Clinico Universitario San Cecilio, Hospital Donostia, Hospital Universitario Central de Asturias, Hospital Universitario de la Ribera, Hospital Costa del Sol, Hospital General Universitario Dr. Balmis, Hospital de Sagunto, Hospital Lluis Alcanyís de Xàtiva, Hospital Universitario Lucus Augusti, Hospital del Mar, Hospital Universitario Virgen de la Arrixaca, Hospital Clinic of Barcelona
- Study start
- 21 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients (18 years and over) with asthma diagnosed at least one year before will be enrolled from the asthma clinics of selected hospitals. Every group (at each participating site) should include 35% of patients over 60 years old considering that this age-group has higher risk of infection and worse prognosis than the younger one.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
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 |
|---|---|---|
| PCRAlso: SerologyDepending 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. | Diagnostic test | – |
Primary outcome
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,
Time frame: 2 years
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma,using PCR test
3 secondary outcomes
To describe the seroprevalence of Bordetella pertussis in adult patients with asthma
Time frame: 2 years
To describe the seroprevalence of RSV in adult patients with asthma
Time frame: 2 years
To evaluate the severity and control of the asthma caused by either BP or RSV infection
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Background: PubMed 29037454Guiso 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.
- Background: PubMed 29302815Weinberger 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.
- Background: PubMed 32220516Leong 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.
- Background: PubMed 30321305Mbayei 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.
- Background: PubMed 32298213Jenkins 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.
- Background: PubMed 29482390Martinon-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.
- BackgroundMartinón-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
- Background: PubMed 33866914Aris 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.
- Background: PubMed 30630694Randi 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.
- Background: PubMed 30220328Rubin 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.
- Background: PubMed 28578723Martini 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.
- Background: PubMed 31666278Marchi 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.
- Access in June 2021Link provided by the sponsor.
- Access in June 2021Link provided by the sponsor.
- Access in June 2021Link provided by the sponsor.
- June 2022Link provided by the sponsor.
- 2022Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Francisco-Javier GONZALEZ BARCALA, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pertussis, run by Hospital Clinico Universitario de Santiago at 1 site in Spain.
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 4 inclusion and 7 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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 Francisco-Javier GONZALEZ BARCALA, MD, PhD (+34607819141, francisco.javier.gonzalez.barcala@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Bordetella pertussis and RSV infections in adult patients with asthma, (time frame: 2 years). 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 NCT06286007, which also lists 71 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 1 Mar 2024.