1. To estimate the incidence and severity of fungal infections during anti-Th17 mAb therapy2. To characterize the determinants (clinical, immunological, mycobiome/microbiomeand genetical) for developing fungal infections during anti-Th17mAb therapy…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
- Fungal infectious disorders
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Incidence and severity of fungal infections.
2) Function immune system.
3) Mycobiome/microbiome.
4) Gene polymorphisms at DNA level.
Secondary outcome
non applicable
Background summary
The incidence and severity of fungal infection and clinical treatment
difficulties during the newly introduced anti-Th17 mAb therapy are yet largely
unknown. It is envisaged that specific individual patients are particularly at
risk to develop these complications, based on clinical, immunological, or
genetic determinants influencing their Th17 anti-infective responses.
Identification of such patients will lead to a personalized healthcare
approach, aimed at better understanding of the potential risks, directed
patient selection and monitoring of Th17-targeted mAb therapy, and may lead to
better prevention and treatment of severe fungal infections in this patient
group.
This asks for a coordinated approach by experts in the field of Candida
infections, fungal immunogenetics, and psoriasis immunotherapy, in an
international collaboration with the drug manufacturers and the governmental
adverse events registries.
Study objective
1. To estimate the incidence and severity of fungal infections during anti-Th17
mAb therapy
2. To characterize the determinants (clinical, immunological,
mycobiome/microbiomeand genetical) for developing fungal infections during
anti-Th17mAb therapy.
Study design
A case-control study will be performed in the Radboudumc. The duration of the
study is 3 years. Participants will be recruited via the BioCAPTURE registry
(Continuous Assessment of Psoriasis Treatment Use Registry with Biologics).
This registry contains all patients on biological treatment in the Radboudumc
and 10 regional hospitals in the Netherlands.
We will use several approaches to investigate the above-described objectives:
* Patient characteristics and patient history will be collected partly via the
BioCAPTURE registry and partly via a questionnaire
* Venous blood will be taken to measure part of the function of the immune
system and to look for gene polymorphisms at DNA level.
* A skin biopsy will be taken to measure another part of the function of the
immune system namely the defensins in epithelial cells.
* Mycobiome/microbiome analysis will be performed on stool, oral, vaginal, and
skin samples using 16s and 18s sequence analysis.
Study burden and risks
Burden:
- Venapuncture
- Skinbiopsy
Risks:
- There will be no risks other than local hematoma related to venous puncture.
- There will be a very small risk of minimal bleeding and infection after
skinbiopsy
Benefit:
- There will be no direct benefits for the subjects enrolled in this study.
Geert grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
* Diagnosis of psoriasis
* Age * 18 years
* Treatment with either a TNF-*-inhibitor for at least 1 year, ustekinumab for at least 1 year, secukinumab for at least 6 months, ixekizumab for at least 6 months or brodalumab for at least 6 months or planning to start treatment with an anti-Th17 mAb therapeutic agent
* Registration in the BioCAPTURE registry
Exclusion criteria
* Pregnancy
* Any active cancer treatment
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 | NL61622.091.17 |