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Completed

NCT Number: NCT03153267

Duration of Doxycycline Treatment in EM Patients

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.

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Key information

Conditions

Erythema Chronicum Migrans Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Erythema Gram-Negative Bacterial Infections Infections Lyme Disease Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical centzer Ljubljana

Ljubljana, Slovenia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • solitary erythema migrans

Exclusion criteria

  • pregnancy or lactation
  • immunocompromised
  • serious adverse event to doxycycline
  • taking antibiotic with antiborrelial activity within 10 days
  • multiple erythema migrans or extracutaneous manifestations of lyme borreliosis

Treatment and study plan

Doxycycline 100 MG Oral Tablet bid, 7 days

Drug

Patients will receive doxycycline for 7 days.

Doxycycline 100 MG Oral Tablet bid, 14 days

Drug

Patients will receive doxycycline for 14 days.

Controls without a history of lyme disease.

Drug

No intervention.

Primary outcomes

  1. Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days

    Time frame: At 12 months after enrollment.

    Objective sequelae and post-treatment subjective new or increased symptoms (NOIS) in patients treated for erythema migrans with doxycycline for 7 or 14 days.

Secondary outcomes

  1. Comparison of nonspecific symptoms in patients with erythema migrans and control subjects

    Time frame: At 12 months after enrollment.

    Number of patients after treatment with doxycycline for 7 or 14 days for erythema migrans and number of control subjects (without a history o Lyme borreliosis) with nonspecific symptoms.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • University of Ljubljana School of Medicine, Slovenia

Registry information

Official study title

Duration of Doxycycline Treatment in Patients With Erythema Migrans (EM). A Randomized Clinical Trial.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 15, 2017
Registry last updated
Mar 25, 2020

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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