Antibiotic Treatment of Multiple Erythema Migrans

This study is currently recruiting participants.
Verified June 2013 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01163994
First received: July 13, 2010
Last updated: June 23, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Multiple Erythema Migrans
Drug: ceftriaxone
Drug: doxycycline
Other: erythema migrans patients treated with doxycycline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

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. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

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. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: June 2010
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163994

Contacts
Contact: Dasa Stupica, MD +386 1 522 2110 cerar.dasa@gmail.com
Contact: Franc Strle, MD +386 1 522 2610 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD    +386 1 522 2110    cerar.dasa@gmail.com   
Contact: Franc Strle, MD    +386 1 5222610    franc.strle@kclj.si   
Sub-Investigator: Petra Bogovic, MD         
Sub-Investigator: Katarina Ogrinc, MD         
Sub-Investigator: Eva Ruzic-Sabljic, MD         
Sub-Investigator: Tjasa Cerar, Dipl Microbiol         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
  More Information

No publications provided

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01163994     History of Changes
Other Study ID Numbers: MEM-0510
Study First Received: July 13, 2010
Last Updated: June 23, 2013
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
erythema migrans
Lyme borreliosis
ceftriaxone treatment
doxycycline treatment
outcome
subjective symptoms

Additional relevant MeSH terms:
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Ceftriaxone
Doxycycline
Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on April 15, 2014