Duration of Antibiotic Treatment of Erythema Migrans

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Franc Strle, University Medical Centre Ljubljana

ClinicalTrials.gov Identifier:

NCT00910715

First received: May 28, 2009

Last updated: July 18, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 28, 2009

Last Updated Date

July 18, 2012

Start Date ^ICMJE

June 2009

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

Objective sequelae and post-treatment subjective symptoms in patients treated for erythema migrans with doxycycline for 10 or 15 days. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00910715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

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).

Original Secondary Outcome Measures ^ICMJE

Comparison of subjective symptoms between patients treated with doxycycline for 10 or 15 days for erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Duration of Antibiotic Treatment of Erythema Migrans

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Erythema Chronicum Migrans

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: EM-10 days doxycycline
Intervention: Drug: doxycycline
Active Comparator: EM-doxycycline 15 days
Intervention: Drug: doxycycline
Placebo Comparator: controls
Intervention: Drug: placebo

Publications *

Stupica D, Lusa L, Ruzić-Sabljić E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. Epub 2012 Apr 20.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

306

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Slovenia

Administrative Information

NCT Number ^ICMJE

NCT00910715

Other Study ID Numbers ^ICMJE

EM-0509

Has Data Monitoring Committee

Responsible Party

Franc Strle, University Medical Centre Ljubljana

Study Sponsor ^ICMJE

University Medical Centre Ljubljana

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Franc Strle, MD

UMC Ljubljana

Information Provided By

University Medical Centre Ljubljana

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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