Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.

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

Study Overview

• Status: Recruiting
• Conditions: Erythema Migrans
• Intervention / Treatment: Drug: EM-amoxicillin 3 x 10 days; Drug: EM-amoxicillin 3 x 14 days; Drug: EM-amoxicillin 2 x 14 days; Other: Controls

• Study Type: Interventional
• Enrollment (Estimated): 510
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daša Stupica, MD PhD; Phone Number: +38631689324; Email: dasa.stupica@kclj.si
• Study Contact Backup: Name: Maša Velušček, MD; Phone Number: +38631332904; Email: masa.veluscek@kclj.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia
    • Recruiting
    • University Medical Centre Ljubljana
    • Contact: Maša Velušček, MD; Phone Number: +386 31 332 904; Email: masa.veluscek@kclj.si
    • Contact: Daša Stupica, MD, PhD; Phone Number: +386 31 689 324; Email: dasa.stupica@kclj.si
  • Ljubljana, Slovenia
    • Not yet recruiting
    • University Medical Centre Ljubljana
    • Contact: Maša Velušček, MD; Phone Number: +386 31 332 904; Email: masa.veluscek@kclj.si
    • Contact: Daša Stupica, MD, PhD; Phone Number: +386 31 689 324; Email: dasa.stupica@kclj.si

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Controls	Other: Controls; No intervention.
Active Comparator: EM-amoxicillin 3 x 10 days	Drug: EM-amoxicillin 3 x 10 days; Patients will receive amoxicillin 500 milligram tid for 10 days
Active Comparator: EM-amoxicillin 3 x 14 days	Drug: EM-amoxicillin 3 x 14 days; Patients will receive amoxicillin 500 milligram tid for 14 days
Active Comparator: EM-amoxicillin 2 x 14 days	Drug: EM-amoxicillin 2 x 14 days; Patients will receive amoxicillin 500 milligram bid for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms	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.	One year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number (frequency) of patients with nonspecific symptoms	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.	One year follow-up

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University of Ljubljana School of Medicine, Slovenia
• Investigators: Principal Investigator: Daša Stupica, MD PhD, Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 24, 2019
• First Submitted That Met QC Criteria: May 24, 2019
• First Posted (Actual): May 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Stomatognathic Diseases; Mouth Diseases; Vector Borne Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Skin Manifestations; Skin Diseases, Bacterial; Tick-Borne Diseases; Borrelia Infections; Spirochaetales Infections; Tongue Diseases; Glossitis; Lyme Disease; Erythema; Erythema Chronicum Migrans; Glossitis, Benign Migratory; Anti-Infective Agents; Anti-Bacterial Agents; Amoxicillin
• Other Study ID Numbers: Amoxy 10-15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No