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出境医 / 临床实验 / Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

Different Amoxicillin Treatment Regimens in Erythema Migrans Patients

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 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, 2021
Estimated Study Completion Date : December 31, 2022
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
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 [ 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

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
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 29, 2019
Last Update Posted Date November 3, 2020
Actual Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2019) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
Official Title  ICMJE Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Erythema Migrans
Intervention  ICMJE
  • Drug: EM-amoxicillin 3 x 10 days
    Patients will receive amoxicillin 500 milligram tid for 10 days
  • Drug: EM-amoxicillin 3 x 14 days
    Patients will receive amoxicillin 500 milligram tid for 14 days
  • Drug: EM-amoxicillin 2 x 14 days
    Patients will receive amoxicillin 500 milligram bid for 14 days
  • Other: Controls
    No intervention.
Study Arms  ICMJE
  • Active Comparator: EM-amoxicillin 3 x 10 days
    Intervention: Drug: EM-amoxicillin 3 x 10 days
  • Active Comparator: EM-amoxicillin 3 x 14 days
    Intervention: Drug: EM-amoxicillin 3 x 14 days
  • Active Comparator: EM-amoxicillin 2 x 14 days
    Intervention: Drug: EM-amoxicillin 2 x 14 days
  • Controls
    Intervention: Other: Controls
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 24, 2019) 		510
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Daša Stupica, MD PhD +38631689324 dasa.stupica@kclj.si
Contact: Maša Velušček, MD +38631332904 masa.veluscek@kclj.si
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03966014
Other Study ID Numbers  ICMJE Amoxy 10-15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Daša Stupica, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE University of Ljubljana School of Medicine, Slovenia
Investigators  ICMJE
Principal Investigator: Daša Stupica, MD PhD Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
PRS Account University Medical Centre Ljubljana
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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