Contact information
Type
Scientific
Primary contact
Prof J.A.J.W. Kluytmans
ORCID ID
Contact details
Vrije University Medical Centre
Department of Medical Microbiology and Infection Control
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
+31 (0)20 444 0552
jan.kluytmans@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
PATHOS study
Study hypothesis
To identify candidate antigens for the development of a prophylactic Staphylococcus aureus vaccine by studying expression profiles of host and pathogen determinants during natural infection.
Ethics approval
Not provided at time of registration
Study design
Multicentre, non-randomised, non-controlled, single armed clinical trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Staphylococcus aureus infection and vaccination
Intervention
Blood will be drawn at days 2, 7 and 14 after the moment that the initial blood and wound cultures were obtained. This will be done simultaneously to drawing blood for routine haematology and chemistry investigations according good clinical practice, so no extra venapuncture is required for participation in the study. At day 2 two nasal swabs will be obtained for assessment of Staphylococcus aureus nasal carriage.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Putative antigen targets for the development of a Staphylococcus aureus vaccine.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2007
Overall trial end date
01/03/2007
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients (greater than 18 years) with S. aureus bacteraemia or wound infection
2. Diagnosis of S. aureus infection within 48 hours after initial cultures
3. Informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Incapacitated patients (Glasgow Coma Scale [GSC] less than 15)
2. Patients with neutropenia (less than 500x 10^6 neutrophils/L)
3. Patients with haematological malignancy
4. Transplantation patients
5. Patients who are treated with immunosuppressive drugs
Recruitment start date
01/11/2007
Recruitment end date
01/03/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
Wyeth Pharmaceuticals B.V. (The Netherlands)
Sponsor details
P.O. Box 255
Hoofddorp
2130 AG
Netherlands
+31 (0)23 567 2567
info-nl@wyeth.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Wyeth Pharmaceuticals B.V. (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary