Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
Primary Purpose
Erythema Migrans
Status
Recruiting
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
EM-amoxicillin 3 x 10 days
EM-amoxicillin 3 x 14 days
EM-amoxicillin 2 x 14 days
Controls
Sponsored by
About this trial
This is an interventional treatment trial for Erythema Migrans
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
Sites / Locations
- University Medical Centre LjubljanaRecruiting
- University Medical Centre Ljubljana
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Other
Arm Label
EM-amoxicillin 3 x 10 days
EM-amoxicillin 3 x 14 days
EM-amoxicillin 2 x 14 days
Controls
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03966014
First Posted
May 24, 2019
Last Updated
May 16, 2022
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
1. Study Identification
Unique Protocol Identification Number
NCT03966014
Brief Title
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
Official Title
Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erythema Migrans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EM-amoxicillin 3 x 10 days
Arm Type
Active Comparator
Arm Title
EM-amoxicillin 3 x 14 days
Arm Type
Active Comparator
Arm Title
EM-amoxicillin 2 x 14 days
Arm Type
Active Comparator
Arm Title
Controls
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
EM-amoxicillin 3 x 10 days
Intervention Description
Patients will receive amoxicillin 500 milligram tid for 10 days
Intervention Type
Drug
Intervention Name(s)
EM-amoxicillin 3 x 14 days
Intervention Description
Patients will receive amoxicillin 500 milligram tid for 14 days
Intervention Type
Drug
Intervention Name(s)
EM-amoxicillin 2 x 14 days
Intervention Description
Patients will receive amoxicillin 500 milligram bid for 14 days
Intervention Type
Other
Intervention Name(s)
Controls
Intervention Description
No intervention.
Primary Outcome Measure Information:
Title
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
Description
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 Outcome Measure Information:
Title
Number (frequency) of patients with nonspecific symptoms
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daša Stupica, MD PhD
Phone
+38631689324
Email
dasa.stupica@kclj.si
First Name & Middle Initial & Last Name or Official Title & Degree
Maša Velušček, MD
Phone
+38631332904
Email
masa.veluscek@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD PhD
Organizational Affiliation
Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD, PhD
Phone
+386 31 689 324
Email
dasa.stupica@kclj.si
First Name & Middle Initial & Last Name & Degree
Maša Velušček, MD
Phone
+386 31 332 904
Email
masa.veluscek@kclj.si
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
Country
Slovenia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daša Stupica, MD, PhD
Phone
+386 31 689 324
Email
dasa.stupica@kclj.si
First Name & Middle Initial & Last Name & Degree
Maša Velušček, MD
Phone
+386 31 332 904
Email
masa.veluscek@kclj.si
12. IPD Sharing Statement
Learn more about this trial
Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
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