Analyses of PAThogen and HOSt determinants in hospitalised patients with a laboratory confirmed infection caused by Staphylococcus aureus: the PATHOS study
ISRCTN | ISRCTN19709160 |
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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
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 |
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jan.kluytmans@vumc.nl |
Study information
Study design | Multicentre, non-randomised, non-controlled, single armed clinical trial |
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Primary study design | Interventional |
Secondary study design | Non randomised controlled trial |
Study setting(s) | Hospital |
Study type | Diagnostic |
Scientific title | |
Study acronym | PATHOS study |
Study objectives | 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(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Primary outcome measure | Putative antigen targets for the development of a Staphylococcus aureus vaccine. |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/11/2007 |
Completion date | 01/03/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 50 |
Key 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 |
Key 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 |
Date of first enrolment | 01/11/2007 |
Date of final enrolment | 01/03/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Vrije University Medical Centre
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Sponsor information
Wyeth Pharmaceuticals B.V. (The Netherlands)
Industry
Industry
P.O. Box 255
Hoofddorp
2130 AG
Netherlands
Phone | +31 (0)23 567 2567 |
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info-nl@wyeth.com | |
Website | http://www.wyeth.nl/ |
https://ror.org/02bzf1224 |
Funders
Funder type
Industry
Wyeth Pharmaceuticals B.V. (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |