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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT02414789 |
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Date of registration:
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08/04/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lyme Borreliosis and Early Cutaneous Diagnostic
DIABOLYC |
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Scientific title:
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Lyme Borreliosis and Early Cutaneous Diagnostic |
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Date of first enrolment:
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August 6, 2015 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02414789 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- 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, ...)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Erythema Migrans
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Intervention(s)
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Procedure: Skin biopsies
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Primary Outcome(s)
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Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
[Time Frame: One year study]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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