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Completed

NCT Number: NCT03584919

Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans

A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).

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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

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • typical solitary erythema migrans as defined by the United States Centers for Disease Control and Prevention. In addition, patients with skin lesion <5 cm in diameter were also included if they recalled a recent tick bite at the site of the skin lesion, had a symptom-free interval between the bite and the onset of the lesion, and reported an expanding skin lesion prior to diagnosis.

Exclusion criteria

  • Lyme disease previously
  • pregnancy or lactation
  • immunocompromised
  • serious adverse reaction to a beta-lactam or tetracycline drug in the past
  • received an antibiotic with known anti-borrelial activity within 10 days
  • multiple erythema migrans lesions
  • presence of an extracutaneous manifestation of Lyme disease

Treatment and study plan

Doxycycline

Drug

patients received oral doxycycline 100 milgrams bid for 15 days

Cefuroxime Axetil 500Mg Tab

Drug

patients received cefuroxime axetil 500 milgrams bid for 15 days

control subjects

Other

no intervention

Primary outcomes

  1. Change from Baseline in Objective Manifestations and Subjective New or Increased Symptoms (NOIS) in Patients Treated for Erythema Migrans With Doxycycline or Cefuroxime Axetil for 15 Days

    Time frame: One year follow-up (follow-up time points at 14 days, 2 months, 6 months, and 12 months after enrolment)

    At each visit patients were examined and asked about the presence of any symptoms that newly developed or had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response was defined as absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response was defined as presence of NOIS. Failure was defined as presence of objective manifestations of Lyme borreliosis or persistence of Borrelia burgdorferi sensu lato in skin at the site of the previous erythema migrans.

Secondary outcomes

  1. Number of Patients (at 12 Months After Treatment With Doxycycline or Cefuroxime Axetil for 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.

    Time frame: 12 months after treatment

    12 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 8 nonspecific symptoms (fatigue, arthralgias, headache, myalgias, paresthesias, concentration difficulties, or irritability) within the preceding week. For both patients and controls, the severity of each individual symptom was graded by the subject on a 10-cm visual analog scale (10 = most severe).

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

Comparison of Doxycycline and Cefuroxime Axetil in Patients With Erythema Migrans

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 12, 2018
Registry last updated
Jul 12, 2018

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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