Duration of Antibiotic Treatment of Erythema Migrans

Erythema Chronicum Migrans Clinical Trial

Official title:

Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910715
• Other study ID #: EM-0509
• Status: Completed
• Phase: N/A
• First received: May 28, 2009
• Last updated: May 28, 2015
• Start date: June 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2015
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• solitary erythema migrans in patients > 15 years

Exclusion Criteria:

• a history of Lyme borreliosis in the past

• pregnancy or lactation

• immunocompromised status

• serious adverse event to doxycycline

• taking antibiotic with antiborrelial activity within 10 days

• multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Erythema
• Erythema Chronicum Migrans

Intervention

Drug:
• doxycycline
doxycycline 100 mg bid, 10 days
• doxycycline
doxycycline 100 mg bid, 15 days
• placebo
control subjects without a history of Lyme borreliosis

Locations

Country	Name	City	State
Slovenia	UMC Ljubljana, Department of Infectious Diseases	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.	At each visit patients were examined and asked about the presence of any symptoms that newly developed/had worsened since erythema migrans. If such symptoms had no other medical explanation they were regarded as new or increased symptoms (NOIS). Complete response=absence of any manifestations of Lyme borreliosis, with return to pre-Lyme borreliosis health status. Partial response=presence of NOIS. Failure=presence of objective manifestations of Lyme borreliosis or persistence of B. burgdorferi sensu lato in skin at the site of the previous erythema migrans.	1 year follow-up	Yes
Secondary	Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.	6 months after treatment patients and controls were asked to complete a written questionnaire asking whether they had had any of 14 nonspecific symptoms (fatigue, malaise, arthralgias, headache, myalgias, pain in the spine, paresthesias, dizziness, nausea, insomnia, sleepiness, forgetfulness, 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).	6 months after treatment	No