Clinical trial NCT01163994: Antibiotic Treatment of Multiple Erythema Migrans
Official title: Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Erythema Migrans
Keywords: erythema migrans
Lyme borreliosis
ceftriaxone treatment
doxycycline treatment
outcome
subjective symptoms
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2010-07-16
Enrollment: 500
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of 15-day ceftriaxone versus 15-day doxycycline treatment in patients with multiple erythema migrans.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
measure: 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.
timeFrame: second assessment at 14 days postenrollment
measure: 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.
timeFrame: third assessment at 2 months postenrollment
measure: 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.
timeFrame: fourth assessment at 6 months postenrollment
measure: 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.
timeFrame: fifth assessment at 12 months postenrollment
Secondary outcomes:
measure: 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.
timeFrame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline
measure: 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.
timeFrame: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter
measure: 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.
timeFrame: second assessment at 6 months postenrollment
measure: 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.
timeFrame: third assessment at 6 months postenrollment
measure: 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.
timeFrame: second assessment at 14 days postenrollment
measure: 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.
timeFrame: third assessment at 2 months postenrollment
measure: 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.
timeFrame: fourth assessment at 6 months postenrollment
measure: 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.
timeFrame: fifth assessment at 12 months postenrollment
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana, Department of Infectious Diseases
Study officials:
affiliation: UMC Ljubljana
name: Franc Strle, MD
role: STUDY_CHAIR
affiliation: UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
name: Dasa Stupica, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.
citation: Stupica D, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.