Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

Not Applicable

Recruiting

• Conditions: Erythema Migrans
• Interventions: Other: Controls; Drug: EM-amoxicillin 3 x 10 days; Drug: EM-amoxicillin 3 x 14 days; Drug: EM-amoxicillin 2 x 14 days

• Registration Number: NCT03966014
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Study Start: 2019-06-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 510

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Controls	-
EM-amoxicillin 3 x 10 days	EM-amoxicillin 3 x 10 days	-
EM-amoxicillin 3 x 14 days	EM-amoxicillin 3 x 14 days	-
EM-amoxicillin 2 x 14 days	EM-amoxicillin 2 x 14 days	-

Primary Outcome Measures

Name	Time	Method
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms	One year follow-up	At each visit physical examination wil be performed and clinical signs indicating objective manifestations of Lyme borreliosis, such as erythema migrans, will be searched for and documented. At each visit patients will be asked an open question about any health-related symptoms that had newly developed or worsened since the onset of erythema migrans. If these symptoms will have no other known medical explanation, they will be regarded as Lyme borreliosis-associated constitutional symptoms at enrolment or post-Lyme borreliosis symptoms at follow-up.

Secondary Outcome Measures

Name	Time	Method
Number (frequency) of patients with nonspecific symptoms	One year follow-up	At each visit patients will be asked to complete a written questionnaire asking whether they had had any of eight non-specific symptoms (fatigue, arthralgias, headache,myalgias, paraesthesias, memory difficulties, concentration difficulties and irritability) within the preceding week.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia