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Erythema Migrans in Elderly

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ClinicalTrials.gov Identifier: NCT03371563
Recruitment Status : Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

December 8, 2017
December 13, 2017
February 20, 2018
January 1, 2006
December 31, 2018   (Final data collection date for primary outcome measure)
  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans [ Time Frame: Study point: at 14 days post-enrollment. ]

    At follow-up at 14 days patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the multiple erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms.

    Complete response to treatment will be defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis was interpreted as failure.

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans with doxycycline for 7 or 14 days [ Time Frame: Study point: at 2 months post-enrollment. ]

    At follow-up at 2 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that hed newly develop or worsened since the onset of the erythema migrans and which will had no other known medical explanation were regarded as post-Lyme symptoms.

    Complete response to treatment was defined as a return to pre-Lyme health status. Partial response will be defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was be interpreted as failure.

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans [ Time Frame: Study point: at 6 months post-enrollment. ]
    At follow-up at 6 months patients were examined physically and were asked an open question about health-related symptoms. Symptoms that had newly develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was interpreted as failure.
  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months postenrollment in patients treated for erythema migrans [ Time Frame: Study point: at 12 months post-enrollment. ]

    At 12 months patients were examined physically and were asked an open question about health-related symptoms.

    Symptoms that had develop or worsened since the onset of the erythema migrans and which had no other known medical explanation were regarded as post-Lyme symptoms. Complete response to treatment was defined as a return to pre-Lyme health status. Partial response was defined as the presence of post-Lyme symptoms, while occurrence of new objective signs of Lyme borreliosis, and/ or persistence of borreliae as detected by culture of skin re-biopsy sample, and/or persistence of erythema migrans at more than 2 months post-treatment was interpreted as failure.

Same as current
Complete list of historical versions of study NCT03371563 on ClinicalTrials.gov Archive Site
Change in occurrence of nonspecific symptoms from baseline to 6 months and to 12 months post-enrollment in patients with erythema migrans and control subjects [ Time Frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment ]
Patients completed a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, memory difficulties, concentration difficulties, irritability) within the preceding week. Control subjects completed the same 8-symptom questionnaire as the patients within 14 days of the examination date of the corresponding patient at enrollment, and again at 6 and 12 months. Patients and controls graded the severity of each individual symptom on a 10-cm visual analogue scale (10 = most severe).
Same as current
Not Provided
Not Provided
 
Erythema Migrans in Elderly
Clinical Course, Serologic Response and Long-term Outcome in Elderly Patients With Early Lyme Borreliosis
The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.
Not Provided
Observational [Patient Registry]
Observational Model: Case-Control
Time Perspective: Prospective
1 Year
Not Provided
Non-Probability Sample
elderly (aged 65 or more years) and younger adult (aged 18-65 years) patients with erythema migrans
  • Lyme Disease
  • Erythema Migrans
  • Elderly Infection
  • Drug: Antibiotics
    Patients were treated with antibiotics for Lyme disease.
  • Other: no intervention
    controls were not given antibiotics
  • elderly patients
    Intervention: Drug: Antibiotics
  • younger adult patients
    Intervention: Drug: Antibiotics
  • controls
    Intervention: Other: no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1200
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • erythema migrans

Exclusion Criteria:

  • pregnancy or lactation
  • immunocompromised
  • taking antibiotic with antiborrelial activity within 10 days
  • received <10 days of antibiotic therapy for erythema migrans
  • had an intercurrent episode of Lyme borreliosis during follow-up
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT03371563
EM-elderly
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Daša Stupica, University Medical Centre Ljubljana
University Medical Centre Ljubljana
Not Provided
Not Provided
University Medical Centre Ljubljana
December 2017