Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
1 other identifier
interventional
200
1 country
2
Brief Summary
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2019
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 29, 2019
CompletedStudy Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 25, 2026
March 1, 2026
8.6 years
May 24, 2019
March 22, 2026
Conditions
Outcome Measures
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.
One year follow-up
Secondary Outcomes (1)
Number (frequency) of patients with nonspecific symptoms
One year follow-up
Study Arms (3)
EM-amoxicillin 3 x 10 days
ACTIVE COMPARATORamoxicillin for 10 days
EM-amoxicillin 3 x 14 days
ACTIVE COMPARATORamoxicillin for 14 days
Controls
OTHERcontrols without Lyme borreliosis
Interventions
Patients will receive amoxicillin 500 milligram tid for 10 days
Patients will receive amoxicillin 500 milligram tid for 14 days
Eligibility Criteria
You may qualify if:
- erythema migrans
You may not qualify if:
- pregnancy
- extracutaneous manifestations of Lyme borreliosis
- immunocompromising state
- serious adverse event to beta lactam antibiotic
- receiving antibiotic with antiborrelial activity within 10 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Medical Centre Ljubljana
Ljubljana, Slovenia
University Medical Centre Ljubljana
Ljubljana, Slovenia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daša Stupica, MD PhD
Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 24, 2019
First Posted
May 29, 2019
Study Start
June 1, 2019
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
March 25, 2026
Record last verified: 2026-03