Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Delafloxacin

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 ).  
     
    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: Delafloxacin. Displaying page 1 of 1.
    EudraCT Number: 2015-003026-14 Sponsor Protocol Number: ML-3341-306 Start Date*: 2016-02-04
    Sponsor Name:Melinta Therapeutics, Inc.
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, COMPARATOR-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVENOUS TO ORAL DELAFLOXACIN IN ADULT SUBJECTS WITH COMMUNITY-ACQUIRED BACTE...
    Medical condition: Community-Acquired Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) LV (Completed) BG (Completed) DE (Completed) SI (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-001082-17 Sponsor Protocol Number: DELA-01 Start Date*: 2019-08-19
    Sponsor Name:MENARINI RICERCHE S.p.A.
    Full Title: A randomized, observer-blinded, active-controlled, Phase IIIb study to compare IV / Oral delafloxacin fixed-dose monotherapy with best available treatments in a microbiologically enriched populatio...
    Medical condition: Acute Bacterial Skin and Skin Structure Infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) GB (Prematurely Ended) HU (Prematurely Ended) LV (Prematurely Ended) SI (Prematurely Ended) ES (Prematurely Ended) AT (Prematurely Ended) PL (Prematurely Ended) EE (Prematurely Ended) BG (Prematurely Ended) HR (Completed) IT (Prematurely Ended) RO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-004983-39 Sponsor Protocol Number: RX-3341-303 Start Date*: 2015-01-26
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IV AND ORAL DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) EE (Completed) LV (Completed) SK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2012-001767-71 Sponsor Protocol Number: RX-3341-302 Start Date*: 2013-06-20
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE BACTERIAL S...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LV (Completed) ES (Completed) BG (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2019-000338-20 Sponsor Protocol Number: MK-7655A-021 Start Date*: 2019-06-26
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2/3 Open-label, Randomized, Active-controlled Clinical Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of MK-7655A in Pediatric Participants From Birth to Less Tha...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) Outside EU/EEA ES (Completed) BG (Completed) GR (Completed) NO (Completed) EE (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-Wed May 28 13:10:22 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA