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Lyme Borreliosis and Early Cutaneous Diagnostic (DIABOLYC)

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ClinicalTrials.gov Identifier: NCT02414789
Recruitment Status : Recruiting
First Posted : April 13, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

April 8, 2015
April 13, 2015
May 22, 2018
August 2015
August 2019   (Final data collection date for primary outcome measure)
Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia [ Time Frame: One year study ]
percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Same as current
Complete list of historical versions of study NCT02414789 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Lyme Borreliosis and Early Cutaneous Diagnostic
Lyme Borreliosis and Early Cutaneous Diagnostic

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).

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Erythema Migrans
Procedure: Skin biopsies
Skin biopsies of patients with Lyme disease (erythema migrans) infected with Borrelia burgdorferi sensu lato will be analyzed by three diagnostic techniques : molecular technique (PCR), biological technique (culture of the bacteria) and proteomics technique (SRM/ MS-MS)
Experimental: SRM / MS-MS
Intervention: Procedure: Skin biopsies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
40
August 2019
August 2019   (Final data collection date for primary outcome measure)

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, ...)
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: Nathalie BOULANGER, MD +33369551449 nathalie.boulanger@chru-strasbourg.fr
Contact: Dan LIPSKER, PhD +33388116197 dan.lipsker@chru-strasbourg.fr
France
 
 
NCT02414789
6084
No
Not Provided
Not Provided
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Not Provided
University Hospital, Strasbourg, France
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP