Antibiotic Treatment of Multiple Erythema Migrans - Full Text View

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: control subjects without a history of Lyme borreliosis 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:

MedlinePlus related topics: Antibiotics Dizziness and Vertigo Fatigue Headache

Drug Information available for: Doxycycline Doxycycline monohydrate Doxycycline Hyclate Ceftriaxone Ceftriaxone sodium Doxycycline calcium

U.S. FDA Resources

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 2013 (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	Other: control subjects without a history of Lyme borreliosis no intervention
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

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:	June 13, 2012
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
Erythema
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Skin Diseases
Ceftriaxone
Doxycycline

Doxycycline hyclate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 19, 2013