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Completed

NCT Number: NCT01475708

Doxycycline in Therapy of Erythema Migrans

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.

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Key information

Conditions

Lyme Borreliosis Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Glossitis Glossitis, Benign Migratory Gram-Negative Bacterial Infections Infections Lyme Disease Mouth Diseases Spirochaetales Infections Stomatognathic Diseases Tick-Borne Diseases Tongue Diseases Vector Borne Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC Ljubljana, Department of Infectious Diseases

Ljubljana, 1000, Slovenia

About this study

Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxycycline

Drug

100 mg PO bid, 14 days

Other names: Doxy

Primary outcomes

  1. 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.

    Time frame: 1 year follow-up

Secondary outcomes

  1. Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.

    Time frame: 1 year follow-up

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 21, 2011
Registry last updated
Mar 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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