Duration of Doxycycline Treatment in MEM Patients

Erythema Chronicum Migrans Clinical Trial

Official title:

Duration of Doxycycline Treatment in Patients With Multiple Erythema Migrans (MEM). A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03337932
• Other study ID #: MEM-Doxy
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: University Medical Centre Ljubljana
• Contact: Daša Stupica, MD, PhD
• Phone: +386 31 689 324
• Email: dasa.stupica[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans

Intervention

Drug:
• Doxycycline 100 milligram Oral Tablet bid, 7 days
Patients will receive doxycycline for 7 days.
• Doxycycline 100 milligram Oral Tablet bid, 14 days
Patients will receive doxycycline for 14 days.
• Controls without a history of lyme disease.
No intervention.

Locations

Country	Name	City	State
Slovenia	University Medical center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Study point: at 14 days post-enrollment.
Primary	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	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.	Study point: at 2 months post-enrollment.
Primary	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	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.	Study point: at 6 months post-enrollment.
Primary	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	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.	Study point: at 12 months post-enrollment.
Secondary	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	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).	Study points will be: at enrollment, at 6, and at 12 months post-enrollment.