Trial Outcomes & Findings for Lyme Borreliosis and Early Cutaneous Diagnostic (NCT NCT02414789)
NCT ID: NCT02414789
Last Updated: 2026-07-13
Results Overview
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
COMPLETED
NA
84 participants
At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).
2026-07-13
Participant Flow
74 participants with erythema migrans planned for inclusion, plus 20 control participants.
Participants with suspected erythema migrans were screened for eligibility and included after informed consent signature. Two skin biopsies were collected from each enrolled participant for Borrelia detection by culture, PCR, and proteomics. Control participants were recruited in the digestive surgery department and included only if Lyme serology was negative.
Participant milestones
| Measure |
Lyme Borreliosis Patients
Patients with Lyme borreliosis
|
Negative Control Patients
Control
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
11
|
|
Overall Study
COMPLETED
|
46
|
10
|
|
Overall Study
NOT COMPLETED
|
28
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lyme Borreliosis
n=74 Participants
Patients with Lyme borreliosis Erythema Migrans (EM)
|
Negative Control Patients
n=11 Participants
Negative control patients with negative Lyme serology
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=74 Participants
|
64 years
n=11 Participants
|
59 years
n=85 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=74 Participants
|
5 Participants
n=11 Participants
|
48 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=74 Participants
|
6 Participants
n=11 Participants
|
37 Participants
n=85 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: At inclusion (Day 0), immediately after skin biopsy sampling, with laboratory analysis performed subsequently (culture up to 8 weeks for Borrelia growth, PCR and targeted proteomics after sample processing).Population: Among the 74 enrolled patients with suspected erythema migrans, only 46 were fully analyzable because of technical issues, insufficient proteomics sensitivity in the initial protocol, loss of study files, and incubator malfunction. Among the 11 negative control participants enrolled, 10 were included in the final analysis because one participant did not have documented negative Lyme serology at the time of biopsy.
Percentage of positive tests with all three techniques (SRM/MS-MS ; PCR ; culture)
Outcome measures
| Measure |
Lyme Borreliosis Patients
n=46 Participants
Patients with Lyme borreliosis
|
Negative Control Patients
n=10 Participants
Control
|
|---|---|---|
|
Compare the Sensitivity (Percentage of Positive Tests) of the SRM / MS-MS to Techniques of PCR and Culture Borrelia
|
0.61 Percentage of positive tests (%)
Interval 0.45 to 0.75
|
0.00 Percentage of positive tests (%)
Interval 0.0 to 0.31
|
Adverse Events
Lyme Borreliosis Patients
Negative Control Patients
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Scientific Coordinator : Dr Nathalie BOULANGER / Principal Investigator : Dr Dan LIPSKER
Hôpitaux Universitaires de Strasbourg - Strasbourg University Hospitals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place