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Completed

NCT Number: NCT01706224

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

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

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Key information

Conditions

Pertussis Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Procedure

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

Data Collection

Other

Electronic Case Report Forms (eCRF)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 15, 2012
Registry last updated
Jan 13, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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