Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Bandemia

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   44336   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    5 result(s) found for: Bandemia. Displaying page 1 of 1.
    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: 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: 2012-002251-42 Sponsor Protocol Number: 3-001 Start Date*: 2012-11-05
    Sponsor Name: Asahi Kasei Pharma America Corporation
    Full Title: A RANDOMIZED, DOUBLE BLIND, PLACEBO–CONTROLLED, PHASE 3 STUDY TO ASSESS THE SAFETY AND EFFICACY OF ART-123 IN SUBJECTS WITH SEVERE SEPSIS AND COAGULOPATHY
    Medical condition: severe sepsis and coagulopathy
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) NL (Completed) HU (Completed) FI (Completed) CZ (Completed) ES (Completed) BG (Prematurely Ended) GB (Completed) DE (Completed) GR (Completed)
    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: 2018-003671-35 Sponsor Protocol Number: SPR994-301 Start Date*: 2019-04-18
    Sponsor Name:Spero Therapeutics, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Prospective Study to Assess the Efficacy, Safety and Pharmacokinetics of Orally Administered Tebipenem Pivoxil Hydrobromide (SPR994) ...
    Medical condition: complicated urinary tract infection or acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10046571 Urinary tract infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) BG (Completed) HU (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    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.
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat May 17 15:09:07 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA