Recruiting NCT03966014
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: EM-amoxicillin 3 x 10 days, EM-amoxicillin 3 x 14 days, Controls.
- Who it may be relevant to
- Registry conditions: Erythema Migrans. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
Overview
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
Interventions
- Drug EM-amoxicillin 3 x 10 days
Patients will receive amoxicillin 500 milligram tid for 10 days - Drug EM-amoxicillin 3 x 14 days
Patients will receive amoxicillin 500 milligram tid for 14 days - Other Controls
No intervention.
Primary outcome measures
- Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms [Time frame: One year follow-up]
Secondary outcome measures (1)
- Number (frequency) of patients with nonspecific symptoms [Time frame: One year follow-up]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Slovenia · 2 centers
- University Medical Centre Ljubljana — Ljubljana
- University Medical Centre Ljubljana — Ljubljana
Identifiers
NCT: NCT03966014 · Amoxy 10-14