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Clinical trials for Oritavancin

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    6 result(s) found for: Oritavancin. Displaying page 1 of 1.
    EudraCT Number: 2007-001774-88 Sponsor Protocol Number: TAR-ORI-SD001 Start Date*: 2007-11-15
    Sponsor Name:Targanta Therapeutics Corporation
    Full Title: Nuvocid™ (oritavancin) at Single or Infrequent Doses for the Treatment of Complicated Skin and Skin Structure Infections (SIMPLIFI)
    Medical condition: Complicated skin and skin structure infections (cSSSI).
    Disease: Version SOC Term Classification Code Term Level
    9.1 10040872 Skin infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-001297-63 Sponsor Protocol Number: MLORI201 Start Date*: 2023-04-13
    Sponsor Name:Melinta Therapeutics, LLC
    Full Title: A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin Versus Standard of Care for the Treatment of Pediatric Subjects...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) RO (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-005415-26 Sponsor Protocol Number: TMC-ORI-11-01 Start Date*: 2015-03-19
    Sponsor Name:Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age with Suspected or Confirmed Bacteri...
    Medical condition: Gram positive bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2010-021424-94 Sponsor Protocol Number: TMC-ORI-10-01 Start Date*: 2012-03-16
    Sponsor Name:The Medicines Company
    Full Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin for the Treatment of Patients with Acute Bacterial Skin and Skin...
    Medical condition: Treatment of Patients with acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10065240 Wound infection bacterial PT
    14.0 10021881 - Infections and infestations 10040872 Skin infection PT
    14.0 10021881 - Infections and infestations 10042343 Subcutaneous abscess PT
    14.0 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    14.0 10021881 - Infections and infestations 10007882 Cellulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021720-10 Sponsor Protocol Number: TMC-ORI-10-02 Start Date*: 2012-03-16
    Sponsor Name:The Medicines Company
    Full Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin for the Treatment of Patients with Acute Bacterial Skin and Skin...
    Medical condition: Treatment of Patients with acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10065240 Wound infection bacterial PT
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    14.1 10021881 - Infections and infestations 10042343 Subcutaneous abscess PT
    14.1 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    14.1 10021881 - Infections and infestations 10007882 Cellulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-000953-38 Sponsor Protocol Number: MK-1986-014 Start Date*: 2018-02-07
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA
    Trial results: View results
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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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