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Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

U

University Medical Centre Ljubljana

Status

Enrolling

Conditions

Erythema Migrans

Treatments

Other: Controls
Drug: EM-amoxicillin 3 x 14 days
Drug: EM-amoxicillin 2 x 14 days
Drug: EM-amoxicillin 3 x 10 days

Study type

Interventional

Funder types

Other

Identifiers

NCT03966014
Amoxy 10-15

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.

Enrollment

510 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • erythema migrans

Exclusion criteria

  • pregnancy
  • extracutaneous manifestations of Lyme borreliosis
  • immunocompromising state
  • serious adverse event to beta lactam antibiotic
  • receiving antibiotic with antiborrelial activity within 10 days

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

510 participants in 4 patient groups

EM-amoxicillin 3 x 10 days
Active Comparator group
Treatment:
Drug: EM-amoxicillin 3 x 10 days
EM-amoxicillin 3 x 14 days
Active Comparator group
Treatment:
Drug: EM-amoxicillin 3 x 14 days
EM-amoxicillin 2 x 14 days
Active Comparator group
Treatment:
Drug: EM-amoxicillin 2 x 14 days
Controls
Other group
Treatment:
Other: Controls

Trial contacts and locations

1

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Central trial contact

Maša Velušček, MD; Daša Stupica, MD PhD

Data sourced from clinicaltrials.gov

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