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Duration of Doxycycline Treatment in MEM Patients

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ClinicalTrials.gov Identifier: NCT03337932
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

October 24, 2017
November 9, 2017
February 20, 2018
January 1, 2018
January 2024   (Final data collection date for primary outcome measure)
  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [ Time Frame: Study point: at 14 days post-enrollment. ]

    At follow-up at 14 days patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be 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 will be interpreted as failure.

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple 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 will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be 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, 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 will be interpreted as failure.

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [ Time Frame: Study point: at 6 months post-enrollment. ]

    At follow-up at 6 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be 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, 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 will be interpreted as failure.

  • Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 12 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days [ Time Frame: Study point: at 12 months post-enrollment. ]

    At 12 months patients will be examined physically and will be asked an open question about health-related symptoms. Symptoms that will newly develop or worsen since the onset of the multiple erythema migrans and which will have no other known medical explanation will be 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, 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 will be interpreted as failure.

Same as current
Complete list of historical versions of study NCT03337932 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 multiple erythema migrans and control subjects [ Time Frame: Study points will be: at enrollment, at 6, and at 12 months post-enrollment. ]

Patients will complete 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 will complete 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 will grade the severity of each individual symptom on a 10-cm visual analogue scale (10 = most severe).

Same as current
Not Provided
Not Provided
 
Duration of Doxycycline Treatment in MEM Patients
Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Erythema Chronicum Migrans
  • Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days
    Patients will receive doxycycline for 7 days.
  • Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days
    Patients will receive doxycycline for 14 days.
  • Drug: Controls without a history of lyme disease.
    No intervention.
  • Active Comparator: MEM-7 days doxycycline
    Intervention: Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days
  • Active Comparator: MEM-14 days doxycycline
    Intervention: Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days
  • Placebo Comparator: Controls
    Intervention: Drug: Controls without a history of lyme disease.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Same as current
January 2024
January 2024   (Final data collection date for primary outcome measure)

Inclusion Criteria:

• multiple erythema migrans

Exclusion Criteria:

  • pregnancy or lactation
  • immunocompromised
  • serious adverse event to doxycycline
  • taking antibiotic with antiborrelial activity within 10 days
  • extracutaneous manifestations of lyme borreliosis
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact: Daša Stupica, MD, PhD +386 31 689 324 dasa.stupica@kclj.si
Contact: Maša Velušček, MD +386 1 522 21 10 masa.veluscek@kclj.si
Slovenia
 
 
NCT03337932
MEM-Doxy
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Daša Stupica, University Medical Centre Ljubljana
University Medical Centre Ljubljana
Not Provided
Not Provided
University Medical Centre Ljubljana
December 2017

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