|- candidate number||2700|
|- NTR Number||NTR1035|
|- Date ISRCTN created||5-sep-2007|
|- date ISRCTN requested||31-aug-2007|
|- Date Registered NTR||13-aug-2007|
|- Secondary IDs||N/A |
|- Public Title||Analyzes of pathogen and host determinants in hospitalized patients with a laboratory confirmed infection caused by Staphylococcus aureus: the PATHOS Study.|
|- Scientific Title||Analyzes of pathogen and host determinants in hospitalized patients with a laboratory confirmed infection caused by Staphylococcus aureus: the PATHOS Study.|
|- ACRONYM||PATHOS Studie|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Staphylococcus aureus, Vaccine, Antigen, Determinant|
|- Inclusion criteria||1. Adult patients (>18 years) with S. aureus bateraemia or wound infection;|
2. Diagnosis of S. aureus infection within 48 hours after initial cultures;
3. Informed consent.
|- Exclusion criteria||1. Incapacitated patients (GSC<15);|
2. Patients with neutropenia (< 500x 10e6 neutrophils/L);
3. Patients with haematological malignancy;
4. Transplantation patients;
5. Patients who are treated with immunsuppressive drugs.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-nov-2007|
|- planned closingdate||1-mrt-2007|
|- Target number of participants||50|
|- Interventions||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.|
|- Primary outcome||Putative antigen targets for the development of a Staphylococcus aureus vaccine.|
|- Secondary outcome||N/A|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Prof.dr. J.A.J.W. Kluytmans|
|- CONTACT for SCIENTIFIC QUERIES||Prof.dr. J.A.J.W. Kluytmans|
|- Sponsor/Initiator ||Wyeth Pharmaceuticals B.V. , VU University Medical Center, Department of Medical Microbiology & Infection Control|
(Source(s) of Monetary or Material Support)
|Wyeth Pharmaceuticals BV|
|- Brief summary||Staphylococcus aureus is the leading nosocomial pathogen worldwide. Nasal carriage is an important risk factor for spread of endogenous en exogenous infection with this bacteria. The development of a prophylactic vaccine against S. aureus infection is one of the possible interventions to control infection with this pathogen. To select putative antigens for the development of such a vaccine, antigen and antibody expression profiles should be studied during natural infection with S. aureus.|
In this study we aim to study pathogen and host determinants of S. aureus infection by collecting blood samples and nasal swabs from patients with a S. aureus bacteraemia or wound infection to study host and pathogen determinants of S. aureus natural infection.
The study will be conducted at the VU University Medical Center in Amsterdam and the Amphia Hospital in Breda. Only adult patients will be recruited and those who are incapacitated or have underlying immunological disease are excluded.
Recruitment of patients will start at the beginning of November and will probably be completed by the end of February.
|- Main changes (audit trail)|
|- RECORD||13-aug-2007 - 16-nov-2009|