Comparing different amoxicillin treatments for erythema migrans
Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
This study tests which length of amoxicillin treatment works best for people with erythema migrans, a common symptom of Lyme disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 2 sites (Ljubljana and 1 other locations) |
| Trial ID | NCT03966014 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of various amoxicillin treatment regimens in patients diagnosed with erythema migrans, a common manifestation of Lyme disease. Participants will be assigned to receive one of four treatment protocols: amoxicillin for 10 days, amoxicillin for 14 days, or a control group. The goal is to determine which regimen provides the best outcomes in terms of symptom resolution and overall efficacy. The study will involve close monitoring of patient responses to the different treatment durations.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with erythema migrans who meet the inclusion criteria.
Not a fit: Patients who are pregnant, have extracutaneous manifestations of Lyme borreliosis, or are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to optimized treatment protocols for erythema migrans, improving patient outcomes and recovery times.
How similar studies have performed: While there have been studies on antibiotic treatments for Lyme disease, this specific comparison of amoxicillin regimens is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * erythema migrans 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
Where this trial is running
Ljubljana and 1 other locations
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Not_yet_recruiting)
Study contacts
- Principal investigator: Daša Stupica, MD PhD — Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
- Study coordinator: Daša Stupica, MD PhD
- Email: dasa.stupica@kclj.si
- Phone: +38631689324
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.