Primary objectives:To evaluate the pathogen host interactions between S. aureus and NS patients:o IgG and IgG4 responses against S. aureus antigens in NS patients will be compared with IgG and IgG4 responses against antigens of other bacteria (e.g.…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- IgG antibody levels against S. aureus antigens, and a panel of other
bacterial antigens (e.g. Pseudomonas aeruginosa, Streptococcus pneumoniae)
measured in serum of NS patients using a Luminex assay, and compared to IgG
antibody levels in healthy S. aureus carriers and non-carriers, AD patients and
EB patients.
- A list of S. aureus proteins produced in the skin of NS patients.
Secondary outcome
- Differences in IgG and IgG4 antibody levels in NS patients over time.
- Identification and characterization of S. aureus (skin and nose) in NS
patients.
Background summary
Netherton syndrome (NS) patients frequently experience skin infections and the
presence of Staphylococcus aureus (S. aureus) on the skin and mucosa of these
patients has been described in multiple studies. Little is known about the
strategies used by the bacteria to colonize and interact with the patients
skin/local immune system. To understand this pathogen host interaction better
we want to investigate which proteins are made by the bacteria and the
immunological countermeasures of the host.
Study objective
Primary objectives:
To evaluate the pathogen host interactions between S. aureus and NS patients:
o IgG and IgG4 responses against S. aureus antigens in NS patients will be
compared with IgG and IgG4 responses against antigens of other bacteria (e.g.
Pseudomonas aeruginosa, Streptococcus pneumoniae) to determine whether NS
patients respond differently towards S. aureus then other bacteria in
comparison to healthy S. aureus carriers and non-carriers, AD patients and EB
patients.
o Local production of S. aureus proteins will be studied by performing proteome
analyses on NS skin biopsies.
Secondary objectives:
o To evaluate changes in the IgG and IgG4 responses in NS patients over time
o To assess and characterize the cultured (skin and nose) S. aureus isolates in
NS patients using several techniques
Study design
This is an explorative observational study. Collection of all control group
data is not part of the current study protocol.
Study burden and risks
Risks assessment: Blood drawing is a routine clinical procedure and is
generally safe, besides the risk of a local hematoma after blood collection.
Taking swabs is non-invasive and is not associated with specific risks. Filling
in the questionnaires may take some time for the patient. The skin biopsy is
optional. A skin biopsy is a routine dermatological procedure and is generally
safe, however there is a small risk of bleeding, infection and/or a small scar.
Benefits and group relatedness: patients will not directly benefit from the
study. However, participation in the study will generate new knowledge on the
pathogen host interaction in NS which will be beneficial to the scientific
community worldwide and accelerate the search for therapeutic strategies for
NS.
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Doctor Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with NS by an expert professional
- Aged 16 years or above
- Able to read patient information, fill out questionnaires and provide
informed consent
Exclusion criteria
- Systemic antibiotics within the previous 4 weeks
- Topical antibiotics within the previous 7 days
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 | NL85267.078.23 |