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出境医 / 临床实验 / Inflammatory Responses in Solitary and Multiple Erythema Migrans
Inflammatory Responses in Solitary and Multiple Erythema Migrans
Study Description
Brief Summary:
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Erythema Migrans | Other: antibiotic treatment |
Study Design
| Study Type : | Observational |
| Actual Enrollment : | 134 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Retrospective |
| Official Title: | Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis |
| Actual Study Start Date : | June 1, 2006 |
| Actual Primary Completion Date : | December 31, 2016 |
| Actual Study Completion Date : | May 31, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
erythema migrans
patients with erythema migrans
|
Other: antibiotic treatment
Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days
|
Outcome Measures
Primary Outcome Measures :
- inflammatory proteins in erythema migrans patients [ Time Frame: at enrollment ]The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum of patients at enrollment (during active infection).
Biospecimen Retention: Samples Without DNA
serum
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adult patients with erythema migrans
Criteria
Inclusion Criteria:
- erythema migrans in patients > 18 years
- Borrelia afzelii isolated from skin
Exclusion Criteria:
- pregnancy or immunocompromising conditions
- taking antibiotic with antiborrelial activity within 10 days
Contacts and Locations
Locations
| Slovenia | |
| University Medical Centre Ljubljana | |
| Ljubljana, Slovenia | |
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana School of Medicine, Slovenia
Investigators
| Principal Investigator: | Daša Stupica, MD PhD | University Medical Centre Ljubljana |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | June 5, 2019 | ||||
| First Posted Date | June 10, 2019 | ||||
| Last Update Posted Date | June 11, 2019 | ||||
| Actual Study Start Date | June 1, 2006 | ||||
| Actual Primary Completion Date | December 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
inflammatory proteins in erythema migrans patients [ Time Frame: at enrollment ] The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum of patients at enrollment (during active infection).
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Inflammatory Responses in Solitary and Multiple Erythema Migrans | ||||
| Official Title | Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis | ||||
| Brief Summary | 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Case-Only Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description:
serum
|
||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients with erythema migrans | ||||
| Condition | Erythema Migrans | ||||
| Intervention | Other: antibiotic treatment
Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days
|
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| Study Groups/Cohorts | erythema migrans
patients with erythema migrans
Intervention: Other: antibiotic treatment
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
134 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | May 31, 2019 | ||||
| Actual Primary Completion Date | December 31, 2016 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Slovenia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03980015 | ||||
| Other Study ID Numbers | MEM vs EM cyto | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Daša Stupica, University Medical Centre Ljubljana | ||||
| Study Sponsor | University Medical Centre Ljubljana | ||||
| Collaborators | University of Ljubljana School of Medicine, Slovenia | ||||
| Investigators |
|
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| PRS Account | University Medical Centre Ljubljana | ||||
| Verification Date | June 2019 | ||||
