Lyme Borreliosis and Early Cutaneous Diagnostic
- Conditions
- Erythema Migrans
- 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
- 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)
Centre Hospitalo-Universitaire Jean Minjoz
🇫🇷Besancon, France
Centre Hospitalier William Morey
🇫🇷Chalon-sur-Saône, France
Hôpital Pasteur
🇫🇷Colmar, France
Hôpital E. Muller
🇫🇷Mulhouse, France
Hôpital Robert Debré
🇫🇷Reims, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Hôpital Bel Air
🇫🇷Thionville, France
Centre Hospitalo-Universitaire Jean Minjoz🇫🇷Besancon, France