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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?

Lyme Borreliosis

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:Doxycycline100 mg PO bid, 14 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.

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

Study Status

Completed

Start Date: May 2011

Completed Date: November 2014

Phase:

Type: Observational

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01475708

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