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Antibiotic Treatment of Multiple Erythema Migrans

Primary Purpose

Multiple Erythema Migrans

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
ceftriaxone
doxycycline
erythema migrans patients treated with doxycycline
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Erythema Migrans focused on measuring erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms

Eligibility Criteria

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

Inclusion Criteria:

  • multiple erythema migrans in patients > 15 years

Exclusion Criteria:

  • a history of Lyme borreliosis in the past
  • pregnancy or lactation
  • immunocompromised status
  • serious adverse event to doxycycline or beta lactam antibiotic
  • taking antibiotic with antiborrelial activity within 10 days

Sites / Locations

  • UMC Ljubljana, Department of Infectious DiseasesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

No Intervention

Active Comparator

Arm Label

MEM-ceftriaxone

MEM-doxycycline

controls

EM-doxycycline

Arm Description

Outcomes

Primary Outcome Measures

Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.

Secondary Outcome Measures

Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.

Full Information

First Posted
July 13, 2010
Last Updated
May 4, 2017
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT01163994
Brief Title
Antibiotic Treatment of Multiple Erythema Migrans
Official Title
Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Erythema Migrans
Keywords
erythema migrans, Lyme borreliosis, ceftriaxone treatment, doxycycline treatment, outcome, subjective symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MEM-ceftriaxone
Arm Type
Active Comparator
Arm Title
MEM-doxycycline
Arm Type
Active Comparator
Arm Title
controls
Arm Type
No Intervention
Arm Title
EM-doxycycline
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ceftriaxone
Intervention Description
intravenously, 2 g, qd, 15 days
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
orally, 100 mg, bid, 15 days
Intervention Type
Other
Intervention Name(s)
erythema migrans patients treated with doxycycline
Intervention Description
orally, 100 mg, bid, 15 days
Primary Outcome Measure Information:
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time Frame
enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time Frame
second assessment at 14 days postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time Frame
third assessment at 2 months postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time Frame
fourth assessment at 6 months postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
Time Frame
fifth assessment at 12 months postenrollment
Secondary Outcome Measure Information:
Title
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time Frame
enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time Frame
enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter
Title
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time Frame
second assessment at 6 months postenrollment
Title
Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
Time Frame
third assessment at 6 months postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time Frame
second assessment at 14 days postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time Frame
third assessment at 2 months postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time Frame
fourth assessment at 6 months postenrollment
Title
Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
Time Frame
fifth assessment at 12 months postenrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: multiple erythema migrans in patients > 15 years Exclusion Criteria: a history of Lyme borreliosis in the past pregnancy or lactation immunocompromised status serious adverse event to doxycycline or beta lactam antibiotic taking antibiotic with antiborrelial activity within 10 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dasa Stupica, MD
Phone
+386 1 522 2110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Franc Strle, MD
Phone
+386 1 522 2610
Email
franc.strle@kclj.si
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD
Organizational Affiliation
UMC Ljubljana
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD
Organizational Affiliation
UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Ljubljana, Department of Infectious Diseases
City
Ljubljana
ZIP/Postal Code
1525
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dasa Stupica, MD
Phone
+386 1 522 2110
Email
cerar.dasa@gmail.com
First Name & Middle Initial & Last Name & Degree
Franc Strle, MD
Phone
+386 1 5222610
Email
franc.strle@kclj.si
First Name & Middle Initial & Last Name & Degree
Petra Bogovic, MD
First Name & Middle Initial & Last Name & Degree
Katarina Ogrinc, MD
First Name & Middle Initial & Last Name & Degree
Eva Ruzic-Sabljic, MD
First Name & Middle Initial & Last Name & Degree
Tjasa Cerar, Dipl Microbiol

12. IPD Sharing Statement

Citations:
PubMed Identifier
30075748
Citation
Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
Results Reference
derived
PubMed Identifier
29385444
Citation
Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.
Results Reference
derived

Learn more about this trial

Antibiotic Treatment of Multiple Erythema Migrans

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