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Duration of Antibiotic Treatment of Erythema Migrans

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ClinicalTrials.gov Identifier: NCT00910715
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : July 18, 2012
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana

May 28, 2009
June 1, 2009
October 5, 2011
July 18, 2012
June 2, 2017
June 2009
November 2010   (Final data collection date for primary outcome measure)
Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. [ Time Frame: 1 year follow-up ]
At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.
Objective sequelae and post-treatment subjective symptoms in patients treated for erythema migrans with doxycycline for 10 or 15 days. [ Time Frame: 1 year follow-up ]
Complete list of historical versions of study NCT00910715 on ClinicalTrials.gov Archive Site
Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms. [ Time Frame: 6 months after treatment ]

6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, concentration difficulties, or irritability) within the preceding week.

For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).

Comparison of subjective symptoms between patients treated with doxycycline for 10 or 15 days for erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ]
Not Provided
Not Provided
 
Duration of Antibiotic Treatment of Erythema Migrans
Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.
The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Erythema Chronicum Migrans
  • Drug: doxycycline
    doxycycline 100 mg bid, 10 days
  • Drug: doxycycline
    doxycycline 100 mg bid, 15 days
  • Drug: placebo
    control subjects without a history of Lyme borreliosis
  • Active Comparator: EM-10 days doxycycline
    Intervention: Drug: doxycycline
  • Active Comparator: EM-doxycycline 15 days
    Intervention: Drug: doxycycline
  • Placebo Comparator: controls
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
400
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • solitary 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
  • taking antibiotic with antiborrelial activity within 10 days
  • multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis
Sexes Eligible for Study: All
15 Years and older   (Child, Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
 
NCT00910715
EM-0509
No
Not Provided
Not Provided
Franc Strle, University Medical Centre Ljubljana
University Medical Centre Ljubljana
Not Provided
Study Chair: Franc Strle, MD UMC Ljubljana
University Medical Centre Ljubljana
May 2017

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