Trial record 10 of 30 for: lyme AND Skin

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Doxycycline in Therapy of Erythema Migrans

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ClinicalTrials.gov Identifier: NCT01475708

Recruitment Status : Completed

First Posted : November 21, 2011

Last Update Posted : March 24, 2016

Sponsor:

Information provided by (Responsible Party):

Franc Strle, University Medical Centre Ljubljana

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Lyme Borreliosis	Drug: Doxycycline

Detailed Description:

Patients with erythema migrans treated with doxycycline for two weeks will be followed-up for one year (at 2 weeks, 2, 6 and 12 months) clinically and also by filling in the questionnaire to assess the presence of certain symptoms. Also the control group of their friends or relatives without a history of Lyme borreliosis will be included. The presence of their (unspecific) symptoms will also be recorded by the questionnaire at the time of enrollment and at 6 and 12 months.

Study Design


Study Type :	Observational
Actual Enrollment :	400 participants
Observational Model:	Case Control
Time Perspective:	Prospective
Official Title:	Doxycycline in Therapy of Erythema Migrans - do the Accompanying Symptoms Influence the Outcome?
Study Start Date :	May 2011
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Doxycycline Doxycycline monohydrate Doxycycline hyclate Doxycycline calcium

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
no symptoms patients with erythema migrans and no additional newly onset symptoms treated with doxycycline	Drug: Doxycycline 100 mg PO bid, 14 days Other Name: Doxy
mild symptoms patients with erythema migrans and mild unspecific newly onset symptoms treated with doxycycline	Drug: Doxycycline 100 mg PO bid, 14 days Other Name: Doxy
severe symptoms-lumbar puncture patients with erythema migrans and newly onset intense "neurologic" symptoms with lumbar puncture performed, treated with doxycycline	Drug: Doxycycline 100 mg PO bid, 14 days Other Name: Doxy

Outcome Measures

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 ]

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 ]

Biospecimen Retention: Samples Without DNA

whole blood, serum, cerebrospinal fluid, skin tissue

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	15 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01475708

Locations


Slovenia
UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia, 1000

Sponsors and Collaborators

University Medical Centre Ljubljana

Investigators


Study Chair:	Franc Strle, MD PhD	UMC Ljubljana

More Information


Responsible Party:	Franc Strle, M.D., PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier:	NCT01475708 History of Changes
Other Study ID Numbers:	EM-DOXY
First Posted:	November 21, 2011 Key Record Dates
Last Update Posted:	March 24, 2016
Last Verified:	March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Franc Strle, University Medical Centre Ljubljana:


Lyme borreliosis Erythema migrans Doxycycline Subjective symptoms Outcome

Additional relevant MeSH terms:


Skin Diseases Lyme Disease Skin Diseases, Bacterial Skin Diseases, Infectious Erythema Erythema Chronicum Migrans Glossitis, Benign Migratory Borrelia Infections Gram-Negative Bacterial Infections Bacterial Infections Tick-Borne Diseases Spirochaetales Infections	Infection Glossitis Tongue Diseases Mouth Diseases Stomatognathic Diseases Doxycycline Anti-Bacterial Agents Anti-Infective Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents

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