| 1 |
NCT03462329 |
Not yet recruiting |
Patient's Pretreatment Expectations About Post-Lyme Symptoms |
|
- Drug: Antibiotics (preferentially oral doxycycline 100 mg bid)
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
- (and 2 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03462329 |
Pretreatment expectations |
|
June 1, 2018 |
June 1, 2022 |
June 1, 2022 |
March 12, 2018 |
March 12, 2018 |
|
|
| 2 |
NCT03371563 |
Active, not recruiting |
Erythema Migrans in Elderly |
- Lyme Disease
- Erythema Migrans
- Elderly Infection
|
- Drug: Antibiotics
- Other: no intervention
|
Observational |
|
- University Medical Centre Ljubljana
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days postenrollment in patients treated for erythema migrans
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months postenrollment in patients treated for erythema migrans with doxycycline for 7 or 14 days
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months postenrollment in patients treated for erythema migrans
- (and 2 more...)
|
1200 |
All |
18 Years and older (Adult, Senior) |
NCT03371563 |
EM-elderly |
|
January 1, 2006 |
December 31, 2018 |
December 31, 2018 |
December 13, 2017 |
February 20, 2018 |
|
|
| 3 |
NCT01518192 |
Completed
Has Results |
Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome |
- Erythema Migrans
- Post-Lyme Disease Symptoms
|
- Drug: doxycycline
- Drug: cefuroxime axetil
|
Interventional |
Phase 4 |
- University Medical Centre Ljubljana
- Slovenian Research Agency
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 14 Days
- Adverse Events
- Objective Lyme Disease Manifestations and Post-Lyme Disease Symptoms at 2 Months
- (and 5 more...)
|
544 |
All |
15 Years and older (Child, Adult, Senior) |
NCT01518192 |
EM-DC |
|
June 2006 |
November 2007 |
January 2009 |
January 25, 2012 |
January 25, 2012 |
January 25, 2012 |
- Institute of Microbiology and Immunology, Medical Faculty, University of Ljubljana
Ljubljana, Slovenia - Department of Infectious Diseases, University Medical Center Ljubljana, Ljubljana, Slovenia
Ljubljana, Slovenia
|
| 4 |
NCT02414789 |
Recruiting |
Lyme Borreliosis and Early Cutaneous Diagnostic |
|
|
Interventional |
Not Applicable |
- University Hospital, Strasbourg, France
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Compare the sensitivity (percentage of positive tests) of the SRM / MS-MS to techniques of PCR and culture Borrelia
|
40 |
All |
18 Years and older (Adult, Senior) |
NCT02414789 |
6084 |
DIABOLYC |
August 2015 |
August 2019 |
August 2019 |
April 13, 2015 |
September 8, 2017 |
|
- Centre Hospitalo-Universitaire Jean Minjoz
Besancon, France - Centre Hospitalier William Morey
Chalon-sur-Saône, France - Hôpital Pasteur
Colmar, France - (and 4 more...)
|
| 5 |
NCT01475708 |
Completed |
Doxycycline in Therapy of Erythema Migrans |
|
|
Observational |
|
- University Medical Centre Ljubljana
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- Comparing of objective sequelae and post-treatment subjective symptoms in three groups of erythema migrans patients treated with doxycycline: with no accompanying symptoms, with mild and with severe symptoms at the beginning.
- Comparison of subjective symptoms between erythema migrans patients treated with doxycycline and control subjects without a history of Lyme borreliosis.
|
400 |
All |
15 Years and older (Child, Adult, Senior) |
NCT01475708 |
EM-DOXY |
|
May 2011 |
October 2014 |
November 2014 |
November 21, 2011 |
March 24, 2016 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
| 6 |
NCT03238274 |
Completed |
Sofia 2 Lyme FIA Whole Blood Clinical Study |
- Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)
|
- Device: Sofia 2 Lyme FIA testing
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Detection of anti-B. burgdorferi IgG / IgM antibody
|
597 |
All |
1 Year and older (Child, Adult, Senior) |
NCT03238274 |
CS-0267-01 |
|
June 6, 2017 |
December 15, 2017 |
December 15, 2017 |
August 3, 2017 |
March 20, 2018 |
|
- NECCR Primacare Research, LLC
Fall River, Massachusetts, United States - Main Road Family Medicine
South Westport, Massachusetts, United States - Essentia Institute of Rural Health
Duluth, Minnesota, United States - (and 8 more...)
|
| 7 |
NCT00132327 |
Recruiting |
Analysis of Lyme Disease Lesions |
- Erythema Migrans Lesions
- Erythema Migrans
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
60 |
All |
18 Years and older (Adult, Senior) |
NCT00132327 |
050219
05-I-0219 |
|
August 17, 2005 |
|
|
August 19, 2005 |
March 29, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 8 |
NCT00910715 |
Completed
Has Results |
Duration of Antibiotic Treatment of Erythema Migrans |
- Erythema Chronicum Migrans
|
- Drug: doxycycline
- Drug: placebo
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Objective Sequelae and Post-treatment Subjective New or Increased Symptoms (NOIS)in Patients Treated for Erythema Migrans With Doxycycline for 10 or 15 Days.
- Number of Patients (at 6 Months After Treatment With Doxycycline for 10 or 15 Days for Erythema Migrans) and Number of Control Subjects (Without a History of Lyme Borreliosis) With Nonspecific Symptoms.
|
306 |
All |
15 Years and older (Child, Adult, Senior) |
NCT00910715 |
EM-0509 |
|
June 2009 |
November 2010 |
November 2010 |
June 1, 2009 |
June 2, 2017 |
July 18, 2012 |
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
| 9 |
NCT02147249 |
Recruiting |
Cytokines and Chemokines in Erythema Migrans |
|
- Drug: antibiotic treatment
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
- Medical University of Vienna
- Harvard University
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- inflammatory proteins in erythema migrans patients
- gene polymorphisms in erythema migrans patients
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT02147249 |
EM-0613 |
|
July 2013 |
December 2017 |
|
May 26, 2014 |
May 5, 2017 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
| 10 |
NCT01368341 |
Completed |
Comparing 3 Antibiotic Regimes for Erythema Migrans in General Practice |
- Erythema Migrans
- Erythema Chronicum Migrans
- Borreliosis
- (and 2 more...)
|
- Drug: Doxycycline
- Drug: Phenoxymethylpenicillin
- Drug: Amoxicillin
|
Interventional |
Phase 4 |
- Morten Lindbaek
- Norwegian Institute of Public Health
- Sorlandet Hospital HF
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Duration of Erythema migrans (EM)
- Subjective Health Complaints (SHC)
- Borrelia antibodies
- (and 3 more...)
|
225 |
All |
18 Years and older (Adult, Senior) |
NCT01368341 |
EUDRACT 2010-023747 |
NorTick_EM |
June 2011 |
December 2013 |
December 2014 |
June 7, 2011 |
December 12, 2014 |
|
- Antibiotic Centre for Primary Care, University of Oslo
Oslo, Norway
|
| 11 |
NCT03337932 |
Recruiting |
Duration of Doxycycline Treatment in MEM Patients |
- Erythema Chronicum Migrans
|
- Drug: Doxycycline 100 milligram Oral Tablet bid, 7 days
- Drug: Doxycycline 100 milligram Oral Tablet bid, 14 days
- Drug: Controls without a history of lyme disease.
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 14 days post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 2 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- Occurrence of objective clinical manifestations of Lyme borreliosis and post-Lyme symptoms at 6 months post-enrollment in patients treated for multiple erythema migrans with doxycycline for 7 or 14 days
- (and 2 more...)
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT03337932 |
MEM-Doxy |
|
January 1, 2018 |
January 2024 |
January 2024 |
November 9, 2017 |
February 20, 2018 |
|
- University Medical center Ljubljana
Ljubljana, Slovenia
|
| 12 |
NCT03501407 |
Not yet recruiting
New |
Understanding Tick-borne Diseases |
|
- Diagnostic Test: Blood samples
- Diagnostic Test: skin biopsy
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Isolate new microorganisms—both unknown or unexpected—from patients suffering from unexplainable symptoms following tick bites
|
130 |
All |
18 Years and older (Adult, Senior) |
NCT03501407 |
2017-002 |
OHTICKS |
June 2018 |
June 2019 |
June 2020 |
April 18, 2018 |
April 18, 2018 |
|
|
| 13 |
NCT03153267 |
Recruiting |
Duration of Doxycycline Treatment in EM Patients |
- Erythema Chronicum Migrans
|
- Drug: Doxycycline 100 MG Oral Tablet bid, 7 days
- Drug: Doxycycline 100 MG Oral Tablet bid, 14 days
- Drug: Controls without a history of lyme disease.
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Treatment outcome in patients treated for erythema migrans with doxycycline for 7 or 14 days
- Comparison of nonspecific symptoms in patients with erythema migrans and control subjects
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT03153267 |
EM-Doxy714 |
|
June 1, 2017 |
June 30, 2019 |
June 30, 2020 |
May 15, 2017 |
December 5, 2017 |
|
- University Medical centzer Ljubljana
Ljubljana, Slovenia
|
| 14 |
NCT02446626 |
Recruiting |
Xenodiagnosis After Antibiotic Treatment for Lyme Disease |
|
- Procedure: Skin biopsy
- Procedure: Blood draw
- Other: Xenodiagnosis
|
Interventional |
Phase 1
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- This study is powered to detect difference in the positivity rate between symptomatic and asymptomatic individuals.
- The study will continue to assess the safety of xenodiagnosis in humans.
|
240 |
All |
18 Years and older (Adult, Senior) |
NCT02446626 |
150131
15-I-0131 |
|
May 13, 2015 |
December 1, 2020 |
December 1, 2030 |
May 18, 2015 |
March 29, 2018 |
|
- Mansfield Family Practice
Storrs, Connecticut, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States - Tufts Medical Center
Boston, Massachusetts, United States - New York Medical College
Valhalla, New York, United States
|
| 15 |
NCT00576082 |
Recruiting |
Borrelia Species in Cutaneous Lyme Borreliosis |
|
|
Observational |
|
- University Hospital, Strasbourg, France
- Société de Dermatologie Française
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
900 |
All |
18 Years and older (Adult, Senior) |
NCT00576082 |
3977 |
|
March 2008 |
April 2022 |
April 2022 |
December 18, 2007 |
March 22, 2018 |
|
- Service de Dermatologie, Hôpital Civil
Strasbourg, France - Service des Maladies infectieuses et tropicales, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France
|
| 16 |
NCT01143558 |
Completed |
Searching for Persistence of Infection in Lyme Disease |
- Lyme Disease
- Borrelia Burgdorferi
|
- Procedure: Skin Biopsy
- Device: Xenodiagnosis
- Procedure: Blood Drawing
|
Interventional |
Early Phase 1 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Determine whether xenodiagnosis can detect the continued presence of B. burgdorferi in patients with Lyme disease after antibiotic therapy.
- Assess the safety of the planned xenodiagnostic procedure in humans.
|
45 |
All |
18 Years to 99 Years (Adult, Senior) |
NCT01143558 |
100139
10-I-0139 |
|
August 1, 2010 |
December 30, 2014 |
December 30, 2014 |
June 14, 2010 |
April 5, 2018 |
|
- Mansfield Family Practice
Storrs, Connecticut, United States - National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States - Tufts University
Boston, Massachusetts, United States
|
| 17 |
NCT01163994 |
Recruiting |
Antibiotic Treatment of Multiple Erythema Migrans |
- Multiple Erythema Migrans
|
- Drug: ceftriaxone
- Drug: doxycycline
- Other: erythema migrans patients treated with doxycycline
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients treated for multiple erythema migrans with ceftriaxone or doxycycline for 15 days.
- Comparison of subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, or irritability between patients treated with antibiotic for multiple erythema migrans and control subjects without a history of Lyme borreliosis.
- Objective sequelae and post-treatment subjective symptoms such as fatigue, malaise, arthralgias, headache, myalgias, paresthesias, dizziness, or irritability in patients with solitary versus multiple erythema migrans after antibiotic treatment.
|
500 |
All |
15 Years and older (Child, Adult, Senior) |
NCT01163994 |
MEM-0510 |
|
June 2010 |
October 2017 |
October 2017 |
July 16, 2010 |
May 5, 2017 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
| 18 |
NCT02741609 |
Terminated |
A Multicenter Study to Evaluate a Borrelia Diagnostic Test in Subjects With Early Stage or Late Stage Lyme Disease |
|
- Device: Borrelia Diagnostic Test
|
Interventional |
Not Applicable |
- Advanced Laboratory Services, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Diagnostic accuracy of the Advanced Laboratory Services, Inc. (ALSI) Borrelia Diagnostic Test (BDT) culture, for positive and negative predictive value, as compared to conventional microbiological methods.
- Diagnostic accuracy of ALSI culture for early-onset presentation of Lyme disease, as measured by positive and negative predictive value.
- Diagnostic accuracy of ALSI culture for late-onset presentation of Lyme disease, as measured by positive and negative predictive value.
|
218 |
All |
18 Years and older (Adult, Senior) |
NCT02741609 |
IR-12 |
ALSIBDT |
April 2016 |
December 2017 |
January 2018 |
April 18, 2016 |
January 17, 2018 |
|
- Delaware Integrative Medicine
Georgetown, Delaware, United States - Penobscot Bay Medical Center
Rockport, Maine, United States - Infectious Disease/The Research Institute
Springfield, Massachusetts, United States - (and 13 more...)
|
| 19 |
NCT02145754 |
Completed
Has Results |
Culture Media for Borrelia Burgdorferi Sensu Lato |
|
- Other: MKP media
- Other: BSK-H media
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
- University of Ljubljana School of Medicine, Slovenia
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Detection of Borrelia Burgdorferi Sensu Lato by Microscopy in Dark Field (Positive vs. Negative)
|
235 |
All |
18 Years and older (Adult, Senior) |
NCT02145754 |
MKP,BSK-0613 |
|
July 2013 |
December 2014 |
|
May 23, 2014 |
June 30, 2015 |
June 30, 2015 |
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
| 20 |
NCT03201042 |
Recruiting |
Lyme Test Indication Combinations (LyTIC) Study |
|
- Diagnostic Test: PCR based assay
- Diagnostic Test: Serology based assay
- Diagnostic Test: Tcell based assay
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
500 |
All |
5 Years and older (Child, Adult, Senior) |
NCT03201042 |
L3 |
LyTIC |
June 8, 2017 |
December 1, 2018 |
February 2019 |
June 28, 2017 |
April 4, 2018 |
|
- Paradigm Clinical Research
Redding, California, United States - Coastal Connecticut Research
New London, Connecticut, United States - Circle CARE Center
Norwalk, Connecticut, United States - (and 58 more...)
|
| 21 |
NCT00358761 |
Terminated |
Investigation of Southern Tick-Associated Rash Illness (STARI) |
- Southern Tick-Associated Rash Illness
|
|
Observational |
|
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
3 |
All |
14 Years and older (Child, Adult, Senior) |
NCT00358761 |
060207
06-I-0207 |
|
July 20, 2006 |
|
December 11, 2012 |
August 1, 2006 |
April 6, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 22 |
NCT00942006 |
Unknown † |
Doxycycline and Ceftriaxone in Suspected Early Lyme Neuroborreliosis |
- Suspected Early Lyme Neuroborreliosis
|
- Drug: doxycycline
- Drug: ceftriaxone
|
Interventional |
Not Applicable |
- University Medical Centre Ljubljana
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective sequelae and post-treatment subjective symptoms in patients treated for suspected early Lyme neuroborreliosis with normal CSF cell count with doxycycline or ceftriaxone for 14 days.
|
200 |
All |
15 Years and older (Child, Adult, Senior) |
NCT00942006 |
LNB-doxy-ceftriaxone |
|
July 2009 |
November 2010 |
November 2011 |
July 20, 2009 |
July 20, 2009 |
|
- UMC Ljubljana, Department of Infectious Diseases
Ljubljana, Slovenia
|
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