Antibiotic Treatment of Multiple Erythema Migrans

May 4, 2017 updated by: Franc Strle, University Medical Centre Ljubljana

Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1525
        • Recruiting
        • UMC Ljubljana, Department of Infectious Diseases
        • Sub-Investigator:
          • Katarina Ogrinc, MD
        • Sub-Investigator:
          • Eva Ruzic-Sabljic, MD
        • Sub-Investigator:
          • Tjasa Cerar, Dipl Microbiol

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: MEM-ceftriaxone
Drug: ceftriaxone
intravenously, 2 g, qd, 15 days
ACTIVE_COMPARATOR: MEM-doxycycline
Drug: doxycycline
orally, 100 mg, bid, 15 days
NO_INTERVENTION: controls
ACTIVE_COMPARATOR: EM-doxycycline
Other: erythema migrans patients treated with doxycycline
orally, 100 mg, bid, 15 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
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
second assessment at 14 days postenrollment
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
third assessment at 2 months postenrollment
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
fourth assessment at 6 months postenrollment
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
fifth assessment at 12 months postenrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
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
enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter
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
second assessment at 6 months postenrollment
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
third assessment at 6 months postenrollment
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
second assessment at 14 days postenrollment
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
third assessment at 2 months postenrollment
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
fourth assessment at 6 months postenrollment
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
fifth assessment at 12 months postenrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Investigators

  • Principal Investigator: Dasa Stupica, MD, UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

October 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 15, 2010

First Posted (ESTIMATE)

July 16, 2010

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2017

Last Update Submitted That Met QC Criteria

May 4, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-0510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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