Antibiotic Treatment of Multiple Erythema Migrans

NCT ID: NCT01163994

Last Updated: 2017-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2017-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Erythema Migrans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MEM-ceftriaxone

Group Type ACTIVE_COMPARATOR

ceftriaxone

Intervention Type DRUG

intravenously, 2 g, qd, 15 days

MEM-doxycycline

Group Type ACTIVE_COMPARATOR

doxycycline

Intervention Type DRUG

orally, 100 mg, bid, 15 days

controls

Group Type NO_INTERVENTION

No interventions assigned to this group

EM-doxycycline

Group Type ACTIVE_COMPARATOR

erythema migrans patients treated with doxycycline

Intervention Type OTHER

orally, 100 mg, bid, 15 days

Interventions

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ceftriaxone

intravenously, 2 g, qd, 15 days

Intervention Type DRUG

doxycycline

orally, 100 mg, bid, 15 days

Intervention Type DRUG

erythema migrans patients treated with doxycycline

orally, 100 mg, bid, 15 days

Intervention Type OTHER

Eligibility Criteria

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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
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

Dasa Stupica, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Ljubljana, Department of Infectious Diseases Ljubljana, Slovenia

Locations

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UMC Ljubljana, Department of Infectious Diseases

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Dasa Stupica, MD

Role: CONTACT

+386 1 522 2110

Franc Strle, MD

Role: CONTACT

+386 1 522 2610

Facility Contacts

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Dasa Stupica, MD

Role: primary

+386 1 522 2110

Franc Strle, MD

Role: backup

+386 1 5222610

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, Veluscek M, Blagus R, Bogovic P, Rojko T, Cerar T, Strle F. Oral doxycycline versus intravenous ceftriaxone for treatment of multiple erythema migrans: an open-label alternate-treatment observational trial. J Antimicrob Chemother. 2018 May 1;73(5):1352-1358. doi: 10.1093/jac/dkx534.

Reference Type DERIVED
PMID: 29385444 (View on PubMed)

Other Identifiers

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MEM-0510

Identifier Type: -

Identifier Source: org_study_id

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