micSPIDERNCT07812675
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).
StatusNot Yet Recruiting
PhaseNot specified
Primary completion (estimated)
At risk: Primary completion moved at least 3 months later.
See at-risk trials from Centre Hospitalier Universitaire de Nīmes
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Record History
All 2 versions: 2 with changes below.
- Notable Start date pushed from Sep 2026 to Jan 2027
- Primary completion pushed from Sep 2028 to Jan 2029
- Study completion moved earlier from Sep 2029 to Mar 2029
- Study First Submitted
- Notable: the plan changed
Endpoints
Primary
Relative abundance of S. aureus in the SPIDER+ group
Timeframe: Month 0, baseline
Relative abundance of S. aureus in the control group
Timeframe: Month 0, baseline
Relative abundance of S. aureus according to the Physician's Global Assessment score in the SPIDER+ group
Timeframe: Month 0, baseline
Relative abundance of S. aureus according to the Dermatology Quality of Life Index in the SPIDER+ group
Timeframe: Month 0, baseline
Secondary (34)
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Physician's Global Assessment score
Relative abundance of S. aureus within the lesion microbiota in the experimental group according to the Dermatology Quality of Life Index
Relative abundance of species found in the experimental group (SPIDER+ patients)
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: axillary folds
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: nostrils
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Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Relative abundance of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: navel
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: ears
Presence of S. aureus in the experimental group (SPIDER+ patients) at different colonization sites: cheek
Evolution of lesions according to the Physician's Global Assessment score in SPIDER+ patients
Evolution of lesions according to the Dermatology Live Quality Index in SPIDER+ patients
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: axillary folds
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: nostrils
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: navel
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: ears
Staphylococcus aureus carriage in relation to the relative abundance of S. aureus in SPIDER+ lesion sites: cheek
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Alpha diversity
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER + patients: Beta diversity
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: Alpha diversity
Abundance of Staphylococcus aureus and the microbiota (composition, alpha and beta diversity) of a healthy skin area in SPIDER - patients: beta diversity
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: length
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: guanine-cytosine content
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: presence of plasmids
Genomes and phenotypic characteristics of S. aureus strains isolated from SPIDER+ lesion sites, healthy areas, and staphylococcal reservoirs via bacterial culture: genome alignment
Quantification of messenger RNA from S. aureus virulence genes isolated from SPIDER+ lesion sites
Quantification of messenger RNA from S. aureus virulence genes isolated from healthy areas in SPIDER+ patients
Quantification of messenger RNA from S. aureus virulence genes isolated from staphylococcal reservoirs
Real-time monitoring of the growth of S. aureus strains isolated from SPIDER+ lesion sites
Real-time monitoring of the growth of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Biofilm formation of S. aureus strains isolated from SPIDER+ lesion sites
Biofilm formation of S. aureus strains isolated from apparently healthy areas in SPIDER+ patients
Constitution of a biobank of samples taken by swabbing of lesion sites in SPIDER+ patients
Arms and interventions
SPIDER+ group
Patients diagnosed with IBD receiving anti-TNFα therapy with skin lesions such as crusted rhinitis ± inflammatory alopecic scalp lesions ± intertrigo of the large skin folds ± folliculitis (Scalp and Periorificial Inflammatory DERmatis, SPIDER)
SPIDER- group (control group):
Patients diagnosed with IBD receiving anti-TNFα therapy for more than 1 year, WITHOUT dermatological lesions suggestive of SPIDER
Sites
5 sites in 1 country