Duration of Doxycycline Treatment in MEM Patients

NCT03337932 | Recruiting

• 1 other identifier: MEM-Doxy
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Erythema Chronicum Migrans

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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 Outcomes (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

  Study points will be: at enrollment, at 6, and at 12 months post-enrollment.

Study Arms (3)

MEM-7 days doxycycline

ACTIVE COMPARATOR

Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days

MEM-14 days doxycycline

ACTIVE COMPARATOR

Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days

Controls

PLACEBO COMPARATOR

Drug: Controls without a history of lyme disease.

Interventions

Doxycycline 100 milligram Oral Tablet bid, 7 days DRUG

Patients will receive doxycycline for 7 days.

MEM-7 days doxycycline

Doxycycline 100 milligram Oral Tablet bid, 14 days DRUG

Patients will receive doxycycline for 14 days.

MEM-14 days doxycycline

Controls without a history of lyme disease. DRUG

No intervention.

Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• multiple erythema migrans

You may not qualify if:

• pregnancy or lactation
• immunocompromised
• serious adverse event to doxycycline
• taking antibiotic with antiborrelial activity within 10 days
• extracutaneous manifestations of lyme borreliosis

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical center Ljubljana

Ljubljana, Slovenia

RECRUITING

MeSH Terms

Conditions

Erythema Chronicum Migrans

Condition Hierarchy (Ancestors)

Lyme Disease; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Skin Diseases, Bacterial; Skin Diseases, Infectious; Tick-Borne Diseases; Vector Borne Diseases; Erythema; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Daša Stupica, MD PhD

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daša Stupica, MD, PhD

CONTACT

+386 31 689 324; dasa.stupica@kclj.si

Maša Velušček, MD

CONTACT

+386 1 522 21 10; masa.veluscek@kclj.si

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 9, 2017
• Study Start: May 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

SL (1)