Lyme Borreliosis and Early Cutaneous Diagnostic
- Conditions
- Erythema Migrans
- Interventions
- Procedure: Skin biopsies
- Registration Number
- NCT02414789
- Lead Sponsor
- University Hospital, Strasbourg, France
- Brief Summary
Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans).
This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Erythema migrant as criteria EUCALB or atypical form associated to tick's sting
- Patient having signed a consent
- Patient affiliated to a social security scheme
- Prior treatment with antibiotics
- Erythema migrans on the face
- Bleeding disorders
- Anticoagulant treatment
- Inability to give clear information (subject in an emergency situation, understanding of the topic difficulty, ...)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SRM / MS-MS Skin biopsies -
- Primary Outcome Measures
Name Time Method Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia One year study percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
H么pitaux Universitaires de Strasbourg
馃嚝馃嚪Strasbourg, France
H么pital Pasteur
馃嚝馃嚪Colmar, France
Centre Hospitalo-Universitaire Jean Minjoz
馃嚝馃嚪Besancon, France
Centre Hospitalier William Morey
馃嚝馃嚪Chalon-sur-Sa么ne, France
H么pital E. Muller
馃嚝馃嚪Mulhouse, France
H么pital Robert Debr茅
馃嚝馃嚪Reims, France
H么pital Bel Air
馃嚝馃嚪Thionville, France