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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01706224
First received: September 27, 2012
Last updated: January 9, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Pertussis
Procedure: Blood sample
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sero-prevalence of Pertussis Antibodies and Disease Awareness Among Healthcare Professionals in Spain

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    By age and gender, by type of healthcare professional, by hospital department of the healthcare professional, duration of service and time spent with patients.

  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Enrollment: 757
Study Start Date: November 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01706224

Locations
Spain
GSK Investigational Site
Hospitalet de Llobregat, Spain, 08907
GSK Investigational Site
La Coruña, Spain, 15006
GSK Investigational Site
Majadahonda, Spain
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706224     History of Changes
Other Study ID Numbers: 115539
Study First Received: September 27, 2012
Last Updated: January 9, 2014
Health Authority: Spain: Agencia Española del Medicamento y Productos Sanitarios

Keywords provided by GlaxoSmithKline:
Pertussis antibodies
Bordetella pertussis
sero-prevalence
Healthcare professionals (HCP)
Spain

Additional relevant MeSH terms:
Whooping Cough
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014