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Clinical trials for Iclaprim

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   44346   clinical trials with a EudraCT protocol, of which   7374   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    5 result(s) found for: Iclaprim. Displaying page 1 of 1.
    EudraCT Number: 2015-002669-45 Sponsor Protocol Number: ICL-23-ABSSSI1 Start Date*: 2016-02-18
    Sponsor Name:Motif BioSciences Inc.
    Full Title: A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infe...
    Medical condition: Acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) DE (Completed) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-002687-16 Sponsor Protocol Number: ICL-24-ABSSSI2 Start Date*: 2016-05-05
    Sponsor Name:Motif BioSciences Inc.
    Full Title: A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infe...
    Medical condition: Acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens.
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) PT (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2005-001548-21 Sponsor Protocol Number: ICLA-08-CSI1 Start Date*: 2005-06-21
    Sponsor Name:Arpida AG
    Full Title: Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim versus Intravenous Linezolid in Complicated Skin and Skin Structure Infections
    Medical condition: Complicated skin and skin structure infections are predominantly caused by the following Gram-positive pathogens: Staphylococcus aureus, including methicillin-resistant strains, beta hemolytic stre...
    Disease: Version SOC Term Classification Code Term Level
    7.0 10040786 HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003630-18 Sponsor Protocol Number: ICLA-09-CSI2 Start Date*: 2006-01-31
    Sponsor Name:Arpida AG
    Full Title: Phase 3, Randomized, Investigator-Blind, Multi-Center Study to Evaluate Efficacy and Safety of Intravenous Iclaprim Versus Intravenous Linezolid in Complicated Skin and Skin Structure Infections
    Medical condition: Complicated skin and skin structure infections are predominantly caused by the following Gram-positive pathogens: Staphylococcus aureus, including methicillin-resistant strains, beta hemolytic stre...
    Disease: Version SOC Term Classification Code Term Level
    8.1 10040786 HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) GB (Completed) DE (Completed) LV (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-003109-28 Sponsor Protocol Number: ICLA-20-PNE1 Start Date*: 2007-09-28
    Sponsor Name:Arpida AG
    Full Title: Randomized, double-blind, multicenter study to evaluate efficacy and safety of intravenous iclaprim versus vancomycin in the treatment of hospital-acquired, ventilator-associated, or health-care-as...
    Medical condition: Hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10035664 Pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Prematurely Ended) LT (Prematurely Ended)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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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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