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

NCT01706224 | Completed

• 1 other identifier: 115539
• Study Type: observational
• Target: 757
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Pertussis

Keywords

Pertussis antibodies; Bordetella pertussis; sero-prevalence; Healthcare professionals (HCP); Spain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Evaluation of the sero-prevalence of B. pertussis antibodies among healthcare professionals aged ≥ 18 years.

  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.

Study Arms (4)

Group A

Subjects in this group will be all physicians actively working at hospital centres in Spain.

Procedure: Blood sample; Other: Data collection

Group B

Subjects in this group will be all nurses actively working at hospital centres in Spain.

Procedure: Blood sample; Other: Data collection

Group C

Subjects in this group will be all ancillary nursing professionals actively working at hospital centres in Spain.

Procedure: Blood sample; Other: Data collection

Group D

Subjects in this group will be all midwives actively working at hospital centres in Spain.

Procedure: Blood sample; Other: Data collection

Interventions

Blood sample PROCEDURE

Samples will be tested to determine the presence of anti-pertussis antibodies.

Group A; Group B; Group C; Group D

Data collection OTHER

Electronic Case Report Forms (eCRF)

Group A; Group B; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Medical students working as healthcare professionals.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

L'Hospitalet de Llobregat, 08907, Spain

Location

GSK Investigational Site

Majadahonda, Spain

Location

Related Publications (1)

• Rodriguez de la Pinta ML, Castro Lareo MI, Ramon Torrell JM, Garcia de Lomas J, Devadiga R, Reyes J, McCoig C, Tafalla M, Garcia-Corbeira P. Seroprevalence of pertussis amongst healthcare professionals in Spain. Vaccine. 2016 Feb 17;34(8):1109-14. doi: 10.1016/j.vaccine.2015.12.036. Epub 2015 Dec 22.

  PMID: 26718690 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Whooping Cough

Interventions

Blood Specimen Collection; Data Collection

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 15, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 13, 2014

Record last verified: 2014-01

Locations

ES (3)