Antibiotic Treatment of Multiple Erythema Migrans

Not Applicable

• Conditions: Multiple Erythema Migrans
• Interventions: Drug: ceftriaxone; Other: erythema migrans patients treated with doxycycline; Drug: doxycycline

• Registration Number: NCT01163994
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-04
• Last Update Posted: 2017-05-05
• Primary Completion: 2017-10
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MEM-ceftriaxone	ceftriaxone	-
EM-doxycycline	erythema migrans patients treated with doxycycline	-
MEM-doxycycline	doxycycline	-

Primary Outcome Measures

Name	Time	Method
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.	fifth assessment at 12 months postenrollment

Secondary Outcome Measures

Name	Time	Method
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.	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.	third assessment at 6 months postenrollment

Trial Locations

Locations (1)

UMC Ljubljana, Department of Infectious Diseases; 🇸🇮 Ljubljana, Slovenia