Lyme Borreliosis | Doxycycline in Therapy of Erythema Migrans
Lyme Borreliosis research study
What is the primary objective of this study?
The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.
Who is eligible to participate?
Inclusion Criteria: - presence of erythema migrans - >15 years old - informed consent Exclusion Criteria: - pregnancy - lactation - multiple erythema migrans - already treated with antibiotic for this episode of Lyme borreliosis - allergy to doxycycline - treatment with drugs with known interactions with doxycycline - cerebrospinal fluid pleocytosis
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
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:Doxycycline100 mg PO bid, 14 days
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.
no symptomspatients with erythema migrans and no additional newly onset symptoms treated with doxycycline
mild symptomspatients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline
severe symptoms-lumbar puncturepatients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline
Start Date: May 2011
Completed Date: November 2014
Primary Outcome: Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
Secondary Outcome: Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
Study sponsors, principal investigator, and references
Principal Investigator: Franc Strle, MD PhD
Lead Sponsor: University Medical Centre Ljubljana