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Different Amoxicillin Treatment Regimens in EM Patients

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ClinicalTrials.gov Identifier: NCT03966014
Recruitment Status : Not yet recruiting
First Posted : May 29, 2019
Last Update Posted : May 29, 2019
Sponsor:
Collaborator:
University of Ljubljana School of Medicine, Slovenia
Information provided by (Responsible Party):
Daša Stupica, 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.

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

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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.
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EM-amoxicillin 3 x 10 days Drug: EM-amoxicillin 3 x 10 days
Patients will receive amoxicillin 500 MG tid for 10 days

Active Comparator: EM-amoxicillin 3 x 14 days Drug: EM-amoxicillin 3 x 14 days
Patients will receive amoxicillin 500 MG tid for 14 days

Active Comparator: EM-amoxicillin 2 x 14 days Drug: EM-amoxicillin 2 x 14 days
Patients will receive amoxicillin 500 MG bid for 14 days

Controls Other: Controls
No intervention.




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.



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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

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 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

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Responsible Party: Daša Stupica, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03966014     History of Changes
Other Study ID Numbers: Amoxy 10-15
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 29, 2019
Last Verified: May 2019

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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
Erythema Chronicum Migrans
Glossitis, Benign Migratory
Skin Diseases
Skin Manifestations
Signs and Symptoms
Lyme Disease
Borrelia Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Tick-Borne Diseases
Skin Diseases, Bacterial
Spirochaetales Infections
Skin Diseases, Infectious
Infection
Glossitis
Tongue Diseases
Mouth Diseases
Stomatognathic Diseases
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents