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
  Purpose

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


Condition Intervention
Erythema Chronicum Migrans
Drug: doxycycline
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).



Enrollment: 306
Study Start Date: June 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EM-10 days doxycycline Drug: doxycycline
doxycycline 100 mg bid, 10 days
Active Comparator: EM-doxycycline 15 days Drug: doxycycline
doxycycline 100 mg bid, 15 days
Placebo Comparator: controls Drug: placebo
control subjects without a history of Lyme borreliosis

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00910715

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1525
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD UMC Ljubljana
  More Information

No publications provided by University Medical Centre Ljubljana

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT00910715     History of Changes
Other Study ID Numbers: EM-0509
Study First Received: May 28, 2009
Results First Received: October 5, 2011
Last Updated: July 18, 2012
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
erythema migrans
Lyme borreliosis
doxycycline treatment
outcome
subjective symptoms

Additional relevant MeSH terms:
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Skin Diseases
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Doxycycline
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 28, 2014