Antibiotic Treatment of Multiple Erythema Migrans
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ClinicalTrials.gov Identifier: NCT01163994 |
Recruitment Status
:
Recruiting
First Posted
: July 16, 2010
Last Update Posted
: May 5, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Erythema Migrans | Drug: ceftriaxone Drug: doxycycline Other: erythema migrans patients treated with doxycycline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans |
Study Start Date : | June 2010 |
Estimated Primary Completion Date : | October 2017 |
Estimated Study Completion Date : | October 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: MEM-ceftriaxone |
Drug: ceftriaxone
intravenously, 2 g, qd, 15 days
|
Active Comparator: MEM-doxycycline |
Drug: doxycycline
orally, 100 mg, bid, 15 days
|
No Intervention: controls | |
Active Comparator: EM-doxycycline |
Other: erythema migrans patients treated with doxycycline
orally, 100 mg, bid, 15 days
|
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: second assessment at 14 days postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: third assessment at 2 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fourth assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fifth assessment at 12 months postenrollment ]
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter ]
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: second assessment at 6 months postenrollment ]
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: third assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: second assessment at 14 days postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: third assessment at 2 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fourth assessment at 6 months postenrollment ]
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fifth assessment at 12 months postenrollment ]

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Ages Eligible for Study: | 15 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- multiple erythema migrans in patients > 15 years
Exclusion Criteria:
- a history of Lyme borreliosis in the past
- pregnancy or lactation
- immunocompromised status
- serious adverse event to doxycycline or beta lactam antibiotic
- taking antibiotic with antiborrelial activity within 10 days

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): NCT01163994
Contact: Dasa Stupica, MD | +386 1 522 2110 | cerar.dasa@gmail.com | |
Contact: Franc Strle, MD | +386 1 522 2610 | franc.strle@kclj.si |
Slovenia | |
UMC Ljubljana, Department of Infectious Diseases | Recruiting |
Ljubljana, Slovenia, 1525 | |
Contact: Dasa Stupica, MD +386 1 522 2110 cerar.dasa@gmail.com | |
Contact: Franc Strle, MD +386 1 5222610 franc.strle@kclj.si | |
Sub-Investigator: Petra Bogovic, MD | |
Sub-Investigator: Katarina Ogrinc, MD | |
Sub-Investigator: Eva Ruzic-Sabljic, MD | |
Sub-Investigator: Tjasa Cerar, Dipl Microbiol |
Study Chair: | Franc Strle, MD | UMC Ljubljana | |
Principal Investigator: | Dasa Stupica, MD | UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Franc Strle, M.D., PhD, University Medical Centre Ljubljana |
ClinicalTrials.gov Identifier: | NCT01163994 History of Changes |
Other Study ID Numbers: |
MEM-0510 |
First Posted: | July 16, 2010 Key Record Dates |
Last Update Posted: | May 5, 2017 |
Last Verified: | May 2017 |
Keywords provided by Franc Strle, University Medical Centre Ljubljana:
erythema migrans Lyme borreliosis ceftriaxone treatment |
doxycycline treatment outcome subjective symptoms |
Additional relevant MeSH terms:
Glossitis, Benign Migratory 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 Glossitis Tongue Diseases Mouth Diseases Stomatognathic Diseases Doxycycline Ceftriaxone Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents |