Trial record 2 of 34 for:    Open Studies | "Tongue Diseases"

Doxycycline in Therapy of Erythema Migrans

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
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: 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 July 26, 2014