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Antibiotic Treatment of Multiple Erythema Migrans

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

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 16, 2010
Last Update Posted Date May 5, 2017
Study Start Date  ICMJE June 2010
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotic Treatment of Multiple Erythema Migrans
Official Title  ICMJE Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Multiple Erythema Migrans
Intervention  ICMJE
  • Drug: ceftriaxone
    intravenously, 2 g, qd, 15 days
  • Drug: doxycycline
    orally, 100 mg, bid, 15 days
  • Other: erythema migrans patients treated with doxycycline
    orally, 100 mg, bid, 15 days
Study Arms  ICMJE
  • Active Comparator: MEM-ceftriaxone
    Intervention: Drug: ceftriaxone
  • Active Comparator: MEM-doxycycline
    Intervention: Drug: doxycycline
  • No Intervention: controls
  • Active Comparator: EM-doxycycline
    Intervention: Other: erythema migrans patients treated with doxycycline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 11, 2016)
500
Original Estimated Enrollment  ICMJE
 (submitted: July 15, 2010)
720
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01163994
Other Study ID Numbers  ICMJE MEM-0510
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Franc Strle, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Franc Strle, MD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
PRS Account University Medical Centre Ljubljana
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP