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Trial record 6 of 7 for:    Open Studies | "Glossitis"

Antibiotic Treatment of Multiple Erythema Migrans

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University Medical Centre Ljubljana
Sponsor:
Information provided by (Responsible Party):
Franc Strle, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:
NCT01163994
First received: July 13, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Multiple Erythema Migrans
Drug: ceftriaxone
Drug: doxycycline
Other: erythema migrans patients treated with doxycycline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Ceftriaxone and Doxycycline for Treatment of Multiple Erythema Migrans

Resource links provided by NLM:


Further study details as provided by University Medical Centre Ljubljana:

Primary Outcome Measures:
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ] [ Designated as safety issue: Yes ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: second assessment at 14 days postenrollment ] [ Designated as safety issue: Yes ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: third assessment at 2 months postenrollment ] [ Designated as safety issue: Yes ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fourth assessment at 6 months postenrollment ] [ Designated as safety issue: Yes ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days. [ Time Frame: fifth assessment at 12 months postenrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: first assessment at baseline ] [ Designated as safety issue: No ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: enrolling 3 years, 1 year follow-up for individual participant: at baseline and at 14 days, 2, 6, and 12 months thereafter ] [ Designated as safety issue: No ]
  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: second assessment at 6 months postenrollment ] [ Designated as safety issue: No ]
  • Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: third assessment at 6 months postenrollment ] [ Designated as safety issue: No ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: second assessment at 14 days postenrollment ] [ Designated as safety issue: No ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: third assessment at 2 months postenrollment ] [ Designated as safety issue: No ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fourth assessment at 6 months postenrollment ] [ Designated as safety issue: No ]
  • Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment. [ Time Frame: fifth assessment at 12 months postenrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: June 2010
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MEM-ceftriaxone Drug: ceftriaxone
intravenously, 2 g, qd, 15 days
Active Comparator: MEM-doxycycline Drug: doxycycline
orally, 100 mg, bid, 15 days
No Intervention: controls
Active Comparator: EM-doxycycline Other: erythema migrans patients treated with doxycycline
orally, 100 mg, bid, 15 days

  Eligibility

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

Inclusion Criteria:

  • multiple 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 or beta lactam antibiotic
  • taking antibiotic with antiborrelial activity within 10 days
  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: NCT01163994

Contacts
Contact: Dasa Stupica, MD +386 1 522 2110 cerar.dasa@gmail.com
Contact: Franc Strle, MD +386 1 522 2610 franc.strle@kclj.si

Locations
Slovenia
UMC Ljubljana, Department of Infectious Diseases Recruiting
Ljubljana, Slovenia, 1525
Contact: Dasa Stupica, MD    +386 1 522 2110    cerar.dasa@gmail.com   
Contact: Franc Strle, MD    +386 1 5222610    franc.strle@kclj.si   
Sub-Investigator: Petra Bogovic, MD         
Sub-Investigator: Katarina Ogrinc, MD         
Sub-Investigator: Eva Ruzic-Sabljic, MD         
Sub-Investigator: Tjasa Cerar, Dipl Microbiol         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
Study Chair: Franc Strle, MD UMC Ljubljana
Principal Investigator: Dasa Stupica, MD UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia
  More Information

No publications provided

Responsible Party: Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT01163994     History of Changes
Other Study ID Numbers: MEM-0510
Study First Received: July 13, 2010
Last Updated: May 21, 2014
Health Authority: Slovenia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on November 25, 2014