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Multiple Erythema Migrans | Antibiotic Treatment of Multiple Erythema Migrans

Multiple Erythema Migrans research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Multiple Erythema Migrans

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:ceftriaxoneintravenously, 2 g, qd, 15 days

Drug:doxycyclineorally, 100 mg, bid, 15 days

Other:erythema migrans patients treated with doxycyclineorally, 100 mg, bid, 15 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MEM-ceftriaxone

MEM-doxycycline

controls

EM-doxycycline

Study Status

Recruiting

Start Date: June 2010

Completed Date: October 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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.

Secondary Outcome: 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.

Study sponsors, principal investigator, and references

Principal Investigator: Franc Strle, MD

Lead Sponsor: University Medical Centre Ljubljana

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01163994

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