Sero-prevalence of Anti-pertussis Antibodies and Disease Awareness Among Spanish Healthcare Professionals

Study Overview
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Brief Summary
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This study aims to determine the sero-prevalence of anti-pertussis antibodies among healthcare professionals at hospital centres in Spain.

Official Title
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Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain

Conditions
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Pertussis

Intervention / Treatment
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* Procedure: Blood sample
* Other: Data collection
* Other: Data collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from the subject. Subjects who the investigator believes that they can and will comply with the requirements of the protocol. Male and female healthcare professionals aged ≥18 years from selected hospitals. Healthcare professionals in frequent contact with patients in the hospitals. Agreeing for collection of a blood sample for the study. Exclusion Criteria: • Medical students working as healthcare professionals.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Subjects in this group will be all physicians actively working at hospital centres in Spain. | Procedure: Blood sample<br>* Samples will be tested to determine the presence of anti-pertussis antibodies.<br>Other: Data collection<br>* Electronic Case Report Forms (eCRF)<br>Other: Data collection<br>* Questionnaires, active questioning.<br>|
| Group B<br>Subjects in this group will be all nurses actively working at hospital centres in Spain. | Procedure: Blood sample<br>* Samples will be tested to determine the presence of anti-pertussis antibodies.<br>Other: Data collection<br>* Electronic Case Report Forms (eCRF)<br>Other: Data collection<br>* Questionnaires, active questioning.<br>|
| Group C<br>Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain. | Procedure: Blood sample<br>* Samples will be tested to determine the presence of anti-pertussis antibodies.<br>Other: Data collection<br>* Electronic Case Report Forms (eCRF)<br>Other: Data collection<br>* Questionnaires, active questioning.<br>|
| Group D<br>Subjects in this group will be all midwives actively working at hospital centres in Spain. | Procedure: Blood sample<br>* Samples will be tested to determine the presence of anti-pertussis antibodies.<br>Other: Data collection<br>* Electronic Case Report Forms (eCRF)<br>Other: Data collection<br>* Questionnaires, active questioning.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-pertussis (anti-PT) antibody levels. |  | Day 0 of each subject at the time of enrollment. | 
| Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seropositivity status. |  | Day 0 of each subject at the time of enrollment. | 
| Evaluation of the overall sero-prevalence of Bordetella pertussis infection among subjects with respect to anti-PT seronegativity status. |  | Day 0 of each subject at the time of enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years. | By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients. | Day 0 of each subject at the time of enrollment. | 
| Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by vaccination history. |  | Day 0 of each subject at the time of enrollment. | 
| Evaluation of the sero-prevalence of anti-pertussis antibodies among healthcare professionals by previous history of pertussis. |  | Day 0 of each subject at the time of enrollment. | 
| Description of the knowledge and beliefs about whooping cough and vaccination against pertussis among healthcare professionals. |  | Day 0 of each subject at the time of enrollment. | 
| Description of the household composition of healthcare professionals to identify the proportion of healthcare professionals potentially at a higher risk of contracting and transmitting pertussis. |  | Day 0 of each subject at the time of enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pertussis antibodies, Bordetella pertussis, sero-prevalence, Healthcare professionals (HCP), Spain