NCT01163994

Brief Summary

The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

7.3 years

First QC Date

July 13, 2010

Last Update Submit

May 4, 2017

Conditions

Multiple Erythema Migrans

Keywords

erythema migransLyme borreliosisceftriaxone treatmentdoxycycline treatmentoutcomesubjective symptoms

Outcome Measures

Primary Outcomes (5)

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

    enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

    second assessment at 14 days postenrollment

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

    third assessment at 2 months postenrollment

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

    fourth assessment at 6 months postenrollment

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

    fifth assessment at 12 months postenrollment

Secondary Outcomes (8)

  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.

    enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.

    enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter

  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.

    second assessment at 6 months postenrollment

  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.

    third assessment at 6 months postenrollment

  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.

    second assessment at 14 days postenrollment

  • +3 more secondary outcomes

Study Arms (4)

MEM-ceftriaxone

ACTIVE COMPARATOR
Drug: ceftriaxone

MEM-doxycycline

ACTIVE COMPARATOR
Drug: doxycycline

controls

NO INTERVENTION

EM-doxycycline

ACTIVE COMPARATOR
Other: erythema migrans patients treated with doxycycline

Interventions

ceftriaxoneDRUG

intravenously, 2 g, qd, 15 days

MEM-ceftriaxone
doxycyclineDRUG

orally, 100 mg, bid, 15 days

MEM-doxycycline
erythema migrans patients treated with doxycyclineOTHER

orally, 100 mg, bid, 15 days

EM-doxycycline

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • multiple erythema migrans in patients \> 15 years

You may not qualify if:

  • a history of Lyme borreliosis in the past
  • pregnancy or lactation
  • immunocompromised status
  • serious adverse event to doxycycline or beta lactam antibiotic
  • taking antibiotic with antiborrelial activity within 10 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1525, Slovenia

RECRUITING

Related Publications (2)

  • Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.

    PMID: 30075748DERIVED

  • Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.

    PMID: 29385444DERIVED

MeSH Terms

Conditions

Glossitis, Benign MigratoryLyme Disease

Interventions

CeftriaxoneDoxycycline

Condition Hierarchy (Ancestors)

GlossitisTongue DiseasesMouth DiseasesStomatognathic DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsBorrelia InfectionsSpirochaetales InfectionsTick-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

CefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Franc Strle, MD

    UMC Ljubljana

    STUDY CHAIR

  • Dasa Stupica, MD

    UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dasa Stupica, MD

CONTACT

+386 1 522 2110cerar.dasa@gmail.com

Franc Strle, MD

CONTACT

+386 1 522 2610franc.strle@kclj.si

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
M.D., PhD

Study Record Dates

First Submitted

July 13, 2010

First Posted

July 16, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

SL(1)