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Erythema Chronicum Migrans clinical trials

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NCT ID: NCT03980015 Completed - Erythema Migrans Clinical Trials

Inflammatory Responses in Solitary and Multiple Erythema Migrans

Start date: June 1, 2006
Phase:
Study type: Observational

The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.

NCT ID: NCT03956212 Completed - Erythema Migrans Clinical Trials

Inflammatory Mediators in Erythema Migrans

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The main objective of this study is to characterize the inflammatory proteins, gene polymorphisms, and transcriptome profiles in patients with erythema migrans to gain better insight into pathogenesis of early Lyme borreliosis and to define new immune modulators that could serve as biomarkers of disease activity.

NCT ID: NCT03584919 Completed - Clinical trials for Erythema Chronicum Migrans

Comparison of Doxycycline and Cefuroxime Axetil in Erythema Migrans

Start date: June 1, 2006
Phase: N/A
Study type: Interventional

A European, prospective clinical trial in which doxycycline and cefuroxime axetil were compared in the treatment of adult patients with erythema migrans included a control group to address this question. Evaluations of patients were conducted at baseline, 14 days and 2, 6, and 12 months after enrollment. Control subjects were evaluated at baseline and at 6 and 12 months. Subjective complaints that newly developed or intensified since the onset of erythema migrans or since the date of enrollment for controls were referred to as "new or increased symptoms"(NOIS).

NCT ID: NCT03505879 Completed - Lyme Disease Clinical Trials

Next Generation Sequencing Detection of Lyme Disease

Start date: July 24, 2018
Phase:
Study type: Observational

Next Generation Sequencing is capable of sequencing millions of small strands of DNA from a single blood sample, potentially improving its sensitivity compared to PCR testing, which only detects predetermined larger strands of DNA. We will test the ability of NGS to detect Borrelia burgdorferi DNA in the blood of pediatric patients with Lyme disease. We will conduct an observational study of NGS testing on pediatric patients at all stages of Lyme disease. Study involvement will require a single study visit for clinical data collection and blood draw. We will enroll patients at all phases of suspected Lyme disease, collect clinically relevant information, and test for Lyme disease using Next Generation Sequencing and standard Lyme serologic testing. If the patient has multiple erythema migrans, Lyme meningitis, facial nerve palsy, arthritis, or carditis, a B. burgdorferi serum PCR will also be sent. Enrollment and Next Generation Sequencing blood draw will occur before or up to 24 hours after the first dose of antibiotics is administered. We will also study the impact of antibiotics on NGS testing by running the test 6-24 hours after antibiotics are started among a small subset of patients with a multiple erythema migrans rash. Collected data will be analyzed with basic descriptive statistics.

NCT ID: NCT03371563 Completed - Lyme Disease Clinical Trials

Erythema Migrans in Elderly

Start date: January 1, 2006
Phase:
Study type: Observational [Patient Registry]

The investigators will focus on elderly patients with early Lyme borreliosis with the aim of assessing clinical course, serological response and treatment outcome of the disease as compared to younger adults. Furthermore, the investigators will compare the prevalence of nonspecific symptoms among patients and among age-matched controls without a history of Lyme borreliosis.

NCT ID: NCT03238274 Completed - Clinical trials for Borrelia; Infection, Burgdorferi (Erythema Chronicum Migrans)

Sofia 2 Lyme FIA Whole Blood Clinical Study

Start date: June 6, 2017
Phase:
Study type: Observational

The objective of this study is to demonstrate the clinical performance of the Sofia® 2 analyzer and Sofia Lyme FIA test in the CLIA waived test environment in comparison to Comparator Method(s) and/or an FDA cleared predicate test(s) using matched finger-stick, whole blood and serum from symptomatic subjects.

NCT ID: NCT03153267 Completed - Clinical trials for Erythema Chronicum Migrans

Duration of Doxycycline Treatment in EM Patients

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

The purpose of this study is to compare the efficacy of 7-day versus 14-day doxycycline treatment in patients with erythema migrans.

NCT ID: NCT02414789 Completed - Erythema Migrans Clinical Trials

Lyme Borreliosis and Early Cutaneous Diagnostic

DIABOLYC
Start date: August 6, 2015
Phase: N/A
Study type: Interventional

Test and evaluate a new diagnostic method (SRM-MS/MS: Selected Reaction Monitoring- Mass spectrometry) for Lyme Borreliosis on human skin biopsies. Patients included are those with the early skin manifestation (erythema migrans). This new proteomic method will be compared to the two existing method: culture of Borrelia and PCR detection of Borrelia (DNA detection of the bacteria).

NCT ID: NCT02145754 Completed - Erythema Migrans Clinical Trials

Culture Media for Borrelia Burgdorferi Sensu Lato

Start date: July 2013
Phase: N/A
Study type: Interventional

The main purpose of this study is to compare effectiveness of two different culture media for cultivation of Borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.

NCT ID: NCT01518192 Completed - Erythema Migrans Clinical Trials

Comparison of Doxycycline and Cefuroxime Axetil for Treatment of Erythema Migrans: Clinical and Microbiological Outcome

Start date: June 2006
Phase: Phase 4
Study type: Interventional

Background: - While doxycycline is a standard antibiotic for treatment of erythema migrans in Europe as well as in the USA, the effectiveness of cefuroxime axetil in the treatment of adult patients with erythema migrans has been assessed only in the USA where the causative agent of Lyme disease is Borrelia burgdorferi, but not in Europe where the main etiologic agents are B. afzelii and B. garinii. - Controversy exists over the significance and even the existence of post-Lyme disease symptoms because of the high rate of similar background symptoms in the general population. Purpose: The two main purposes of this European, prospective clinical trial in which doxycycline and cefuroxime axetil are compared in the treatment of adult patients with erythema migrans and which included a control group to address the significance of post-Lyme disease symptoms are: - To assess and compare the effectiveness of doxycycline and cefuroxime axetil in the treatment of erythema migrans using clinical and bacteriological criteria (noninferiority testing approach), and - to compare the frequency of post-Lyme disease symptoms in adult patients treated for EM with antibiotics and the frequency of similar symptoms in control subjects without Lyme disease.