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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 16, 2014