search
Back to results

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
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erythema Migrans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
May 24, 2019
Last Updated
May 16, 2022
Sponsor
University Medical Centre Ljubljana
Collaborators
University of Ljubljana School of Medicine, Slovenia
search

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

We'll reach out to this number within 24 hrs