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:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
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 monohydrate 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 ]

Enrollment:	405
Study Start Date:	June 2009
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: EM-10 days doxycycline	Drug: doxycycline doxycycline 100 mg bid, 10 days
Active Comparator: EM-doxycycline 15 days	Drug: doxycycline doxycycline 100 mg bid, 15 days
Placebo Comparator: controls	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:	Dasa Cerar, UMC Ljubljana
ClinicalTrials.gov Identifier:	NCT00910715 History of Changes
Other Study ID Numbers:	EM-0509
Study First Received:	May 28, 2009
Last Updated:	July 14, 2011
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:

Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Skin Diseases

Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Bacterial Agents
Doxycycline
Doxycycline hyclate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 24, 2012