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Antibiotic Treatment of Multiple Erythema Migrans

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ClinicalTrials.gov Identifier: NCT01163994
Recruitment Status : Recruiting
First Posted : July 16, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Erythema Migrans Drug: ceftriaxone Drug: doxycycline Other: erythema migrans patients treated with doxycycline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
Study Start Date : June 2010
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01163994     History of Changes
Other Study ID Numbers: MEM-0510
First Posted: July 16, 2010    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017

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

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