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Doxycycline in Therapy of Erythema Migrans

This study is currently recruiting participants.
Verified December 2012 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01475708
First received: November 16, 2011
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The investigators will compare the outcome of three groups of erythema migrans patients treated with doxycycline: a group without any accompanying symptoms, with mild symptoms and with severe symptoms that require lumbar puncture.


Condition Intervention
Lyme Borreliosis
 Drug: Doxycycline

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

whole blood, serum, cerebrospinal fluid, skin tissue


Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
no symptoms Drug: Doxycycline
100 mg PO bid, 14 days
Other Name: Doxy
mild symptoms Drug: Doxycycline
100 mg PO bid, 14 days
Other Name: Doxy
severe symptoms-LP Drug: Doxycycline
100 mg PO bid, 14 days
Other Name: Doxy

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with erythema migrans reffered to Lyme Borreliosis outpatient clinic of the University Medical Center Ljubljana, Slovenia, Department of Infectious Diseases.

Criteria

Inclusion Criteria:

  • presence of erythema migrans
  • >15 years old
  • informed consent

Exclusion Criteria:

  • pregnancy
  • lactation
  • multiple erythema migrans
  • already treated with antibiotic for this episode of Lyme borreliosis
  • allergy to doxycycline
  • treatment with drugs with known interactions with doxycycline
  • cerebrospinal fluid pleocytosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475708

Contacts
Contact: Katarina Ogrinc, MD PhD +38615224217 katarina.ogrinc1@guest.arnes.si
Contact: Franc Strle, MD PhD +38615222110 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1000
Contact: Katarina Ogrinc, MD PhD     +38615224217     katarina.ogrinc1@guest.arnes.si    
Contact: Franc Strle, MD PhD     +38615222110     franc.strle@kclj.si    
Principal Investigator: Katarina Ogrinc, MD PhD            
Sub-Investigator: Daša Stupica, MD PhD            
Sub-Investigator: Petra Bogovič, MD            
Sub-Investigator: Vera Maraspin Čarman, MD PhD            
Sub-Investigator: Tereza Rojko, MD PhD            
Sub-Investigator: Eva Ružić Sabljić, MD PhD            
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD PhD UMC Ljubljana
  More Information

No publications provided

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01475708     History of Changes
Other Study ID Numbers: EM-DOXY
Study First Received: November 16, 2011
Last Updated: December 5, 2012
Health Authority: Slovenia: Ethics Committee

Keywords provided by University Medical Centre Ljubljana:
Lyme borreliosis
Erythema migrans
Doxycycline
Subjective symptoms
Outcome

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

ClinicalTrials.gov processed this record on June 13, 2013