NCT03153267

Brief Summary

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration 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

First Submitted

Initial submission to the registry

March 16, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 25, 2020

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

March 16, 2017

Last Update Submit

March 24, 2020

Conditions

Erythema Chronicum Migrans

Outcome Measures

Primary Outcomes (1)

  • Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days

    Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.

    At 12 months after enrollment.

Secondary Outcomes (1)

  • Comparison of nonspecific symptoms in patients with erythema migrans and control subjects

    At 12 months after enrollment.

Study Arms (3)

EM-7 days doxycycline

ACTIVE COMPARATOR
Drug: Doxycycline 100 MG Oral Tablet bid, 7 days

EM-14 days doxycycline

ACTIVE COMPARATOR
Drug: Doxycycline 100 MG Oral Tablet bid, 14 days

Controls

PLACEBO COMPARATOR
Drug: Controls without a history of lyme disease.

Interventions

Doxycycline 100 MG Oral Tablet bid, 7 daysDRUG

Patients will receive doxycycline for 7 days.

EM-7 days doxycycline
Doxycycline 100 MG Oral Tablet bid, 14 daysDRUG

Patients will receive doxycycline for 14 days.

EM-14 days doxycycline
Controls without a history of lyme disease.DRUG

No intervention.

Controls

Eligibility Criteria

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

You may qualify if:

  • solitary erythema migrans

You may not qualify if:

  • pregnancy or lactation
  • immunocompromised
  • serious adverse event to doxycycline
  • taking antibiotic with antiborrelial activity within 10 days
  • multiple erythema migrans or extracutaneous manifestations of lyme borreliosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical centzer Ljubljana

Ljubljana, Slovenia

Location

Related Publications (1)

  • Stupica D, Collinet-Adler S, Blagus R, Gomiscek A, Cerar Kisek T, Ruzic-Sabljic E, Veluscek M. Treatment of erythema migrans with doxycycline for 7 days versus 14 days in Slovenia: a randomised open-label non-inferiority trial. Lancet Infect Dis. 2023 Mar;23(3):371-379. doi: 10.1016/S1473-3099(22)00528-X. Epub 2022 Oct 6.

    PMID: 36209759DERIVED

MeSH Terms

Conditions

Erythema Chronicum Migrans

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Lyme DiseaseGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsSkin Diseases, BacterialSkin Diseases, InfectiousTick-Borne DiseasesVector Borne DiseasesErythemaSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Daša Stupica, MD PhD

    University Mecical Centre Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2017

First Posted

May 15, 2017

Study Start

June 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 25, 2020

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)