Lyme Borreliosis and Early Cutaneous Diagnostic

Erythema Migrans Clinical Trial

— DIABOLYC  

Official title:

Lyme Borreliosis and Early Cutaneous Diagnostic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414789
• Other study ID #: 6084
• Status: Completed
• Phase: N/A
• Start date: August 6, 2015
• Est. completion date: February 1, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ...)

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans
• Lyme Disease

Intervention

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)

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia	percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)	One year study