Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

University Medical Centre Ljubljana

Status and phase: Enrolling; Phase 3

Conditions: Erythema Migrans

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03966014

Amoxy 10-14

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: 200 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)

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200 participants in 3 patient groups

EM-amoxicillin 3 x 10 days

Active Comparator group

Description:

amoxicillin for 10 days

Treatment:

Drug: EM-amoxicillin 3 x 10 days

EM-amoxicillin 3 x 14 days

Active Comparator group

Description:

amoxicillin for 14 days

Treatment:

Drug: EM-amoxicillin 3 x 14 days

Controls

Other group

Description:

controls without Lyme borreliosis

Treatment:

Other: Controls