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RecruitingNCT03966014Updated Mar 25, 2026

Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

A Phase 3 interventional study of EM-amoxicillin 3 x 10 days and EM-amoxicillin 3 x 14 days in Erythema Migrans, sponsored by University Medical Centre Ljubljana. Recruiting at 2 sites in Slovenia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-25.

Sponsored by University Medical Centre Ljubljana · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2019; still recruiting 7 years 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.

02

Conditions studied

  • Erythema Migrans
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 200 is close to 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.

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

04

Who can participate

Ages eligible
18 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

  • erythema migrans

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • extracutaneous manifestations of Lyme borreliosis
  • immunocompromising state
  • serious adverse event to beta lactam antibiotic
  • receiving antibiotic with antiborrelial activity within 10 days
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    EM-amoxicillin 3 x 10 days

    amoxicillin for 10 days

    Drug: EM-amoxicillin 3 x 10 days

  • Active comparator
    EM-amoxicillin 3 x 14 days

    amoxicillin for 14 days

    Drug: EM-amoxicillin 3 x 14 days

  • Other
    Controls

    controls without Lyme borreliosis

    Other: Controls

Interventions

  • DrugEM-amoxicillin 3 x 10 days

    Patients will receive amoxicillin 500 milligram tid for 10 days

    Also known as: 10 days

  • DrugEM-amoxicillin 3 x 14 days

    Patients will receive amoxicillin 500 milligram tid for 14 days

    Also known as: 14 days

  • OtherControls

    No intervention.

06

What researchers measure

Primary outcomes

  1. Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms

    At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.

    Time frame: One year follow-up

Secondary outcomes

  1. Number (frequency) of patients with nonspecific symptoms

    At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week.

    Time frame: One year follow-up

07

Study locations

1 of 2 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03966014
Collaborators
University of Ljubljana School of Medicine, Slovenia
Responsible party
Daša Stupica (Principal Investigator, University Medical Centre Ljubljana) — Principal investigator
First posted
May 29, 2019
Start date
Jun 1, 2019
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 25, 2026

Study contacts

Daša Stupica, MD PhD
Contact
dasa.stupica@kclj.si
+38631689324
Maša Velušček, MD
Contact
masa.veluscek@kclj.si
+38631332904
Daša Stupica, MD PhD
principal investigator · Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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