NCT03956212

Brief Summary

The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.6 years

First QC Date

May 15, 2019

Last Update Submit

November 2, 2020

Conditions

Erythema Migrans

Keywords

Lyme BorreliosisInflammationOutcome

Outcome Measures

Primary Outcomes (1)

  • inflammatory proteins in erythema migrans patients

    The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum and if available, skin, of patients during active infection and after treatment.

    up to 12 months follow-up

Secondary Outcomes (1)

  • gene polymorphisms in erythema migrans patients

    at enrollment

Study Arms (1)

erythema migrans patients treated with doxycycline

EXPERIMENTAL

adult patients with erythema migrans will be treated with oral doxycycline

Drug: Doxycycline 7 daysDrug: Doxycycline 14 days

Interventions

Doxycycline 7 daysDRUG

Patient will be treated with doxycycline orally, 100 mg, bid, 7 days

erythema migrans patients treated with doxycycline
Doxycycline 14 daysDRUG

Patient will be treated with doxycycline orally, 100 mg, bid, 14 days

erythema migrans patients treated with doxycycline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • erythema migrans in patients \> 18 years

You may not qualify if:

  • pregnancy or immunocompromising conditions
  • taking antibiotic with antiborrelial activity within 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Glossitis, Benign MigratoryLyme DiseaseInflammation

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

GlossitisTongue DiseasesMouth DiseasesStomatognathic DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Daša Stupica, MD PhD

    University Medical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2019

First Posted

May 20, 2019

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

October 31, 2020

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

SL(1)