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Clinical trials for Borrelia

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    12 result(s) found for: Borrelia. Displaying page 1 of 1.
    EudraCT Number: 2009-010939-40 Sponsor Protocol Number: PLEASE Start Date*: 2010-04-29
    Sponsor Name:UMCN St Radboud
    Full Title: PLEASE Persistent Lyme Empiric Antibiotic Study Europe. A prospective, randomised study comparing two prolonged oral antibiotic strategies after initial intravenous ceftriaxone therapy for patients...
    Medical condition: Persistent Lyme disease Persistent borreliosis
    Disease: Version SOC Term Classification Code Term Level
    12.0 10025169 Lyme disease LLT
    12.0 10025170 Lyme's disease LLT
    12.0 10067559 Lyme borreliosis LLT
    12.0 10006036 Borrelia burgdorferi infection LLT
    12.0 10061591 Borrelia infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-000313-37 Sponsor Protocol Number: T1/2012 Start Date*: 2012-06-07
    Sponsor Name:TYKS
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10025170 Lyme's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-005101-51 Sponsor Protocol Number: RIVM-V/330564/01 Start Date*: 2013-02-05
    Sponsor Name:National Institute of Health and the Environment (Dutch acronym: RIVM)
    Full Title: Tick Test & Prophylaxis Proof
    Medical condition: Lyme disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10025169 Lyme disease PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-000117-39 Sponsor Protocol Number: A2301 Start Date*: 2011-06-14
    Sponsor Name:Ixodes AG.
    Full Title: A Phase 3 randomized, double-blind, placebo-controlled study of SHB004 (10% topical azithromycin) administered locally twice daily for three consecutive days for the prevention of Borreliosis in su...
    Medical condition: Lyme borreliosis
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004862 10067559 Lyme borreliosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005427-20 Sponsor Protocol Number: C4601003 Start Date*: 2022-07-13
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6 VALENT OspA-BASED LYME DISE...
    Medical condition: Prevention of Lyme disease caused by Borrelia species in individuals ≥5 years of age by active immunization
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10025169 Lyme disease PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SE (Trial now transitioned) EE (Prematurely Ended) FI (Trial now transitioned) NL (Trial now transitioned) PL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-011906-40 Sponsor Protocol Number: 27659 Start Date*: 2009-06-22
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The use of antibiotics in therapy resistant Lichen Sclerosus patientes
    Medical condition: Vulvar Lichen Sclerosus
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023384-18 Sponsor Protocol Number: 730901 Start Date*: 2011-03-14
    Sponsor Name:Baxter Innovations GmbH
    Full Title: Randomized, double-blind, phase I/II clinical study to investigate the safety and immunogenicity of a multivalent recombinant OspA Lyme Borreliosis vaccine (mv rOspA LB Vaccine) in healthy subjects...
    Medical condition: -) To obtain safety and immunogenicity data of different dose levels of a mv rOspA LB Vaccine with and without adjuvant in seronegative healthy volunteers aged 18 to 70 years. The outcome shall pro...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004862 10067559 Lyme borreliosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2010-023747-15 Sponsor Protocol Number: 070411 Start Date*: 2011-05-03
    Sponsor Name:University of Oslo
    Full Title: Tick borne diseases in norwegian general practice. A randomized, controlled trial for treatment of erythema migrans in norwegian general practice. A comparison of phneoxymetylpenicillin, amoxicilli...
    Medical condition: Erythema migrans (Early Lyme disease)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10015157 Erythema chronicum migrans LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2009-018143-25 Sponsor Protocol Number: 2010 Start Date*: 2010-05-06
    Sponsor Name:Västra Götalandsregionen
    Full Title: An open label, historical control, study to assess the impact on bacteriological healing of Prednisolone in patients with neuroborreliosis-caused peripheral facial palsy receiving treatment with Do...
    Medical condition: Facialispares orsakad av CNS-infektion med Borrelia burgdorferi. (Neuroborrelios-orsakad facialispares)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052057 Neuroborreliosis LLT
    12.1 10016060 Facial palsy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004187-35 Sponsor Protocol Number: FACE-01 Start Date*: Information not available in EudraCT
    Sponsor Name:Falun Hospital
    Full Title: The FACE (Facial nerve palsy And Cortisone Evaluation) study in children: a randomised double-blind, placebo-controlled, multicenter trial.
    Medical condition: Facial Nerve Palsy (Bells Palsy)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004852 10077335 Facial nerve paresis LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002828-33 Sponsor Protocol Number: ICRC-ICIT-01 Start Date*: 2012-10-10
    Sponsor Name:Fakultní nemocnice u sv. Anny v Brně
    Full Title: RANDOMIZED, MULTICENTRIC STUDY COMPARING THE EFFECT OF TWO REGIMENS OF COMBINED IMMUNOSUPPRESIVE THERAPY IN THE TREATMENT OF INFLAMMATORY CARDIOMYOPATHY CZECH-ICIT (CZECH INFLAMMATORY CARDIOMYOPATH...
    Medical condition: Patients with endomyocardial biopsy (EMB) proven inflammatory cardiomyopathy (ICM) defined by EMB established presence of myocardial inflammation and absence of cardiotropic infectious agents estab...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-003014-28 Sponsor Protocol Number: FARM12JCXN Start Date*: 2017-10-30
    Sponsor Name:UMBERTO I - POLICLINICO DI ROMA
    Full Title: MULTICENTER RANDOMIZED STUDY ON THE EFFICACY OF IMMUNOSUPPRESSION IN PATIENTS WITH VIRUS-NEGATIVE INFLAMMATORY CARDIOMYOPATHY
    Medical condition: virus negative inflammatory cardiomyopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10007541 - Cardiac disorders 10007636 Cardiomyopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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