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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

Brief Summary:
The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with multiple erythema migrans.

Condition or disease Intervention/treatment Phase
Erythema Chronicum Migrans Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days Drug: Controls without a history of lyme disease. Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MEM-7 days doxycycline Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days
Patients will receive doxycycline for 7 days.

Active Comparator: MEM-14 days doxycycline Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days
Patients will receive doxycycline for 14 days.

Placebo Comparator: Controls Drug: Controls without a history of lyme disease.
No intervention.




Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Secondary Outcome Measures :
  1. 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).




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT03337932


Contacts
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

Locations
Slovenia
University Medical center Ljubljana Recruiting
Ljubljana, Slovenia
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   
Sponsors and Collaborators
University Medical Centre Ljubljana

Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03337932     History of Changes
Other Study ID Numbers: MEM-Doxy
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents