Analyses of PAThogen and HOSt determinants in hospitalised patients with a laboratory confirmed infection caused by Staphylococcus aureus: the PATHOS study

ISRCTN ISRCTN19709160
DOI https://doi.org/10.1186/ISRCTN19709160
Secondary identifying numbers N/A
Submission date
05/09/2007
Registration date
05/09/2007
Last edited
05/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof J.A.J.W. Kluytmans
Scientific

Vrije University Medical Centre
Department of Medical Microbiology and Infection Control
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Phone +31 (0)20 444 0552
Email jan.kluytmans@vumc.nl

Study information

Study designMulticentre, non-randomised, non-controlled, single armed clinical trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study acronymPATHOS study
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedStaphylococcus aureus infection and vaccination
InterventionBlood 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 typeOther
Primary outcome measurePutative antigen targets for the development of a Staphylococcus aureus vaccine.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/11/2007
Completion date01/03/2007

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/11/2007
Date of final enrolment01/03/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands

Sponsor information

Wyeth Pharmaceuticals B.V. (The Netherlands)
Industry

P.O. Box 255
Hoofddorp
2130 AG
Netherlands

Phone +31 (0)23 567 2567
Email info-nl@wyeth.com
Website http://www.wyeth.nl/
ROR logo "ROR" https://ror.org/02bzf1224

Funders

Funder type

Industry

Wyeth Pharmaceuticals B.V. (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan