Duration of Antibiotic Treatment of Erythema Migrans

NCT ID: NCT00910715

Last Updated: 2017-06-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-11-30

Brief Summary

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The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans.

Detailed Description

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Conditions

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Erythema Chronicum Migrans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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EM-10 days doxycycline

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

doxycycline 100 mg bid, 10 days

EM-doxycycline 15 days

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

doxycycline 100 mg bid, 15 days

controls

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

control subjects without a history of Lyme borreliosis

Interventions

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doxycycline

doxycycline 100 mg bid, 10 days

Intervention Type DRUG

doxycycline

doxycycline 100 mg bid, 15 days

Intervention Type DRUG

placebo

control subjects without a history of Lyme borreliosis

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Franc Strle

M.D., PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franc Strle, MD

Role: STUDY_CHAIR

UMC Ljubljana

Locations

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UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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Veluscek M, Bajrovic FF, Strle F, Stupica D. Doxycycline-induced photosensitivity in patients treated for erythema migrans. BMC Infect Dis. 2018 Aug 3;18(1):365. doi: 10.1186/s12879-018-3270-y.

Reference Type DERIVED
PMID: 30075748 (View on PubMed)

Stupica D, Lusa L, Ruzic-Sabljic E, Cerar T, Strle F. Treatment of erythema migrans with doxycycline for 10 days versus 15 days. Clin Infect Dis. 2012 Aug;55(3):343-50. doi: 10.1093/cid/cis402. Epub 2012 Apr 20.

Reference Type DERIVED
PMID: 22523260 (View on PubMed)

Other Identifiers

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EM-0509

Identifier Type: -

Identifier Source: org_study_id

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