Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

• Sponsor: University Medical Centre Ljubljana (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03966014
• Collaborator: University of Ljubljana School of Medicine, Slovenia (Other)
• Enrollment: 510
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 55
• Patients Per Site: 255
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Erythema Migrans	Drug: EM-amoxicillin 3 x 10 days; Drug: EM-amoxicillin 3 x 14 days; Drug: EM-amoxicillin 2 x 14 days; Other: Controls	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 510 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
• Actual Study Start Date: Jun 1, 2019
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Controls	Other: Controls; No intervention.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Medical Centre Ljubljana	Ljubljana		Slovenia
2	University Medical Centre Ljubljana	Ljubljana		Slovenia

Sponsors and Collaborators

• University Medical Centre Ljubljana
• University of Ljubljana School of Medicine, Slovenia

Investigators

• Principal Investigator: Daša Stupica, MD PhD, Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana
• ClinicalTrials.gov Identifier: NCT03966014
• Other Study ID Numbers: Amoxy 10-15
• First Posted: May 29, 2019
• Last Update Posted: May 17, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Erythema Chronicum Migrans; Glossitis, Benign Migratory; Erythema; Amoxicillin

Study Results

No Results Posted as of May 17, 2022