Duration of Antibiotic Treatment of Erythema Migrans - Full Text View

Sponsor:	University Medical Centre Ljubljana
Information provided by:	University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT00910715

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:	Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duration of Antibiotic Treatment of Erythema Migrans. A Randomized Clinical Trial.

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics

Drug Information available for: Doxycycline Doxycycline hyclate 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 in patients treated for erythema migrans with doxycycline for 10 or 15 days. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Comparison of subjective symptoms between patients treated with doxycycline for 10 or 15 days for erythema migrans and control subjects without a history of Lyme borreliosis. [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2009
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
EM-10 days doxycycline: Active Comparator	Drug: doxycycline doxycycline 100 mg bid, 10 days
EM-doxycycline 15 days: Active Comparator	Drug: doxycycline doxycycline 100 mg bid, 15 days
controls: No Intervention	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

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

Responsible Party:	UMC Ljubljana ( Dasa Cerar )
Study ID Numbers:	EM-0509
Study First Received:	May 28, 2009
Last Updated:	January 8, 2010
ClinicalTrials.gov Identifier:	NCT00910715 History of Changes
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:

Bacterial Infections
Mouth Diseases
Anti-Infective Agents
Erythema
Antiprotozoal Agents
Borrelia Infections
Erythema Chronicum Migrans
Infection
Gram-Negative Bacterial Infections
Anti-Bacterial Agents
Antimalarials
Antiparasitic Agents
Skin Diseases, Bacterial

Therapeutic Uses
Glossitis
Skin Diseases
Lyme Disease
Tick-Borne Diseases
Pharmacologic Actions
Skin Diseases, Infectious
Spirochaetales Infections
Tongue Diseases
Stomatognathic Diseases
Glossitis, Benign Migratory
Doxycycline

ClinicalTrials.gov processed this record on February 08, 2010