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Status unknownNCT01163994Updated May 5, 2017

Antibiotic Treatment of Multiple Erythema Migrans

An interventional study of ceftriaxone and doxycycline in Multiple Erythema Migrans, sponsored by University Medical Centre Ljubljana. Status unknown at 1 site in Slovenia. Open to participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-05-05.

Sponsored by University Medical Centre Ljubljana · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Erythema Migrans

Keywords

  • erythema migrans
  • Lyme borreliosis
  • ceftriaxone treatment
  • doxycycline treatment
  • outcome
  • subjective symptoms
03

In context

Glossitis, Benign Migratory

25 studies on the registry are indexed under Glossitis, Benign Migratory; 4 are open to participants now.

This study's planned enrollment of 500 is above the median of 200 across 13 interventional studies indexed under Glossitis, Benign Migratory.

Browse Glossitis, Benign Migratory studies →

Lead sponsor

University Medical Centre Ljubljana is the lead sponsor of 296 studies on the registry; 72 are open to participants now.

Browse University Medical Centre Ljubljana studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • multiple erythema migrans in patients > 15 years

Exclusion criteria

Exclusion Criteria:

  • a history of Lyme borreliosis in the past
  • pregnancy or lactation
  • status
  • serious adverse event to doxycycline or beta lactam antibiotic
  • taking antibiotic with antiborrelial activity within 10 days
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (estimated)

Study arms

  • Active comparator
    MEM-ceftriaxone

    Drug: ceftriaxone

  • Active comparator
    MEM-doxycycline

    Drug: doxycycline

  • No intervention
    controls
  • Active comparator
    EM-doxycycline

    Other: erythema migrans patients treated with doxycycline

Interventions

  • Drugceftriaxone

    intravenously, 2 g, qd, 15 days

  • Drugdoxycycline

    orally, 100 mg, bid, 15 days

  • Othererythema migrans patients treated with doxycycline

    orally, 100 mg, bid, 15 days

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

    Time frame: second assessment at 14 days postenrollment

  3. 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.

    Time frame: third assessment at 2 months postenrollment

  4. 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.

    Time frame: fourth assessment at 6 months postenrollment

  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.

    Time frame: fifth assessment at 12 months postenrollment

Secondary outcomes

  1. 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.

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

  2. 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.

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

  3. 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.

    Time frame: second assessment at 6 months postenrollment

  4. 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.

    Time frame: third assessment at 6 months postenrollment

  5. 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.

    Time frame: second assessment at 14 days postenrollment

  6. 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.

    Time frame: third assessment at 2 months postenrollment

  7. 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.

    Time frame: fourth assessment at 6 months postenrollment

  8. 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.

    Time frame: fifth assessment at 12 months postenrollment

07

Study locations

1 of 1 sites recruiting
  • UMC Ljubljana, Department of Infectious Diseases
    Ljubljana, 1525, Slovenia
    Recruiting
    • Dasa Stupica, MD · Contactcerar.dasa@gmail.com · +386 1 522 2110
    • Franc Strle, MD · Contactfranc.strle@kclj.si · +386 1 5222610
    • Petra Bogovic, MD · Sub investigator
    • Katarina Ogrinc, MD · Sub investigator
    • Eva Ruzic-Sabljic, MD · Sub investigator
    • Tjasa Cerar, Dipl Microbiol · Sub investigator
08

References and documents

Publications

  • 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. PubMed 30075748 ↗
  • 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. PubMed 29385444 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01163994
Lead sponsor
University Medical Centre Ljubljana
Responsible party
Franc Strle (M.D., PhD, University Medical Centre Ljubljana) — Principal investigator
First posted
Jul 16, 2010
Start date
Jun 2010
Primary completion
Oct 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
May 5, 2017

Study contacts

Dasa Stupica, MD
Contact
cerar.dasa@gmail.com
+386 1 522 2110
Franc Strle, MD
Contact
franc.strle@kclj.si
+386 1 522 2610
Franc Strle, MD
study chair · UMC Ljubljana
Dasa Stupica, MD
principal investigator · UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Ceftriaxone · Doxycycline

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