Objective: to study host and pathogen determinants of S. aureus infection to identify a putative antigen as target for the development of a prophylactic vaccine against S. aureus.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The identification of candidate antigens for development of a prophylactic S.
aureus vaccine.
Secondary outcome
Not applicable.
Background summary
Staphylococcus aureus is the leading nosocomial pathogen worldwide and poses an
immense burden on health care. Nasal carriage of S. aureus is an important risk
factor for infection in various patient populations. New interventions are
needed to control S. aureus infection; a possible strategy is the development
of a prophylactic vaccine. Analysis of host and pathogen determinants during
early infection with S. aureus is the first step in selection of putative
antigen targets for the development of a vaccine against S. aureus. To
determine the severity of infection, bacterial DNA load and procalcitonine will
be measured.
Study objective
Objective: to study host and pathogen determinants of S. aureus infection to
identify a putative antigen as target for the development of a prophylactic
vaccine against S. aureus.
Study design
Patiënts wit a laboratory confirmed Staphylococcus aureus bacteraemia or wound
infectie are eligible for the study. On days 2, 7 and 14 after the initial
culture was obtained, blood will be drawn for antigen and antibody expression
studies. For bacteriemic patients blood will also be drawn on days 3, 4 and 5.
Also, two nose swabs will be taken on day two for determination of nasal
carriage of S. aureus. All isolates will be stored and typing of these isolates
will be done with AFLP analysis.
Study burden and risks
Blood for study purposes will be drawn simultaneously to drawing blood for
routine clinical determinations according good clinical practice. No extra
venapunction is involved with participation in the study, so no extra risks are
involved for the patient. In general, obtaining nose swabs for culture of S.
aureus is not considered to be of much discomfort and does not involve
additional risks for the patient.
Spicalaan 31
2132 JG Hoofddorp
Nederland
Spicalaan 31
2132 JG Hoofddorp
Nederland
Listed location countries
Age
Inclusion criteria
-Adult patients (>18 years) with laboratory confirmed Staphylococcus aureus bacteraemia or wound infection. The diagnosis of S. aureus infection should be available within 48 hours after cultures were obtained. Patient should give informed consent prior to inclusion.
Exclusion criteria
-Incapacitated patients (Glasgow coma scale <15).
-Patients with neutropenia (<500 x10e6 neutrophils/L)
-Patients with haematological malignancy
-Known immunodeficiency (HIV, cytotoxic chemotherapy, transplantation, etc.).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL16899.029.07 |