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Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

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ClinicalTrials.gov Identifier: NCT03966014
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, University Medical Centre Ljubljana

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
Controls Other: Controls
No intervention.


Outcome Measures
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Primary Outcome Measures :
  1. Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03966014


Contacts
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Contact: Daša Stupica, MD PhD +38631689324 dasa.stupica@kclj.si
Contact: Maša Velušček, MD +38631332904 masa.veluscek@kclj.si

Locations
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Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324    dasa.stupica@kclj.si   
Contact: Maša Velušček, MD    +386 31 332 904    masa.veluscek@kclj.si   
University Medical Centre Ljubljana Not yet recruiting
Ljubljana, Slovenia
Contact: Daša Stupica, MD, PhD    +386 31 689 324    dasa.stupica@kclj.si   
Contact: Maša Velušček, MD    +386 31 332 904    masa.veluscek@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
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Principal Investigator: Daša Stupica, MD PhD Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
More Information
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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    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Erythema Chronicum Migrans
Glossitis, Benign Migratory
Erythema
Skin Diseases
Skin Manifestations
Lyme Disease
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Borrelia Infections
Spirochaetales Infections
 Skin Diseases, Bacterial
Skin Diseases, Infectious
Tick-Borne Diseases
Vector Borne Diseases
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents