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

January 9, 2014 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

757

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Hospitalet de Llobregat, Spain, 08907
        • GSK Investigational Site
      • La Coruña, Spain, 15006
        • GSK Investigational Site
      • Majadahonda, Spain
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthcare professionals actively working and involved with patient care in Spanish hospitals.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 11, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115539

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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