Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

Erythema Migrans Clinical Trial

Official title:

Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966014
• Other study ID #: Amoxy 10-15
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: University Medical Centre Ljubljana
• Contact: Daša Stupica, MD PhD
• Phone: +38631689324
• Email: dasa.stupica[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 510
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans
• Erythema Migrans

Intervention

Drug:
• EM-amoxicillin 3 x 10 days
Patients will receive amoxicillin 500 milligram tid for 10 days
• EM-amoxicillin 3 x 14 days
Patients will receive amoxicillin 500 milligram tid for 14 days
• EM-amoxicillin 2 x 14 days
Patients will receive amoxicillin 500 milligram bid for 14 days

Other:
• Controls
No intervention.

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	University of Ljubljana School of Medicine, Slovenia

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-speci?c symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory dif?culties, concentration dif?culties and irritability) within the preceding week.	One year follow-up