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Clinical trials for Ceftaroline fosamil

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   44334   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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    13 result(s) found for: Ceftaroline fosamil. Displaying page 1 of 1.
    EudraCT Number: 2011-002198-44 Sponsor Protocol Number: P903-21 Start Date*: 2011-07-22
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Medical condition: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003812-22 Sponsor Protocol Number: P903-23 Start Date*: 2011-10-31
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA LT (Completed) LV (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-004013-16 Sponsor Protocol Number: D3720C00001 Start Date*: 2012-03-08
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Multicentre, Randomised, Double-Blind, Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatm...
    Medical condition: Complicated bacterial skin and soft tissue infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) CZ (Completed) BG (Completed) DE (Completed) AT (Completed) PL (Completed) ES (Completed) GB (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003243-34 Sponsor Protocol Number: C2661002/D3720C00009 Start Date*: 2015-02-02
    Sponsor Name:Pfizer Inc.
    Full Title: Open-label, Multicentre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline in Neonates and Young Infants with Late-Onset Sepsis
    Medical condition: Late-onset Sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000005053 10040054 Sepsis, bacteraemia, viraemia and fungaemia NEC HLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) IT (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2012-002182-35 Sponsor Protocol Number: P903-25 Start Date*: 2012-10-22
    Sponsor Name:Cerexa, Inc. (subsidiary of Forest Laboratories)
    Full Title: A Multicenter, Multinational, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Ceftaroline fosamil Versus Ceftriaxone Plus Vancomycin in Adult Subjects with Community-acquired ...
    Medical condition: Community-acquired bacterial pneumonia (CABP)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) HU (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-002203-18 Sponsor Protocol Number: P903-31 Start Date*: 2012-07-18
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With...
    Medical condition: Community-acquired Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10035664 Pneumonia PT
    14.1 10021881 - Infections and infestations 10004051 Bacterial pneumonia, unspecified LLT
    14.1 10021881 - Infections and infestations 10060946 Pneumonia bacterial PT
    14.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA HU (Completed) GR (Completed) ES (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-002508-29 Sponsor Protocol Number: CEFTAROPROPH Start Date*: 2018-02-09
    Sponsor Name:MedUni Vienna, Dept of Anesthesia, Critical Care, Div. of Cardiothoracic and Vascular Anesthesia
    Full Title: Ceftaroline (Zinforo®) as antibiotic prophylaxis for CABG-surgery: An In-vivo microdialysis study
    Medical condition: Antibiotic prophylaxis for CABG surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10036894 Prophylactic antibiotic therapy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-022487-12 Sponsor Protocol Number: CXL-MD-02 Start Date*: 2011-02-25
    Sponsor Name:Cerexa, Inc
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline fosamil and NXL104 Versus Intravenous Doripenem in ...
    Medical condition: Complicated Urinary Tract Infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10054088 Urinary tract infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003914-42 Sponsor Protocol Number: CEFTAROLINE_RRT Start Date*: 2013-11-06
    Sponsor Name:Medizinische Universität Wien, Univ.-Klinik für Innere Medizin I, Klinische Abteilung für Infetionen und Tropenmedizin
    Full Title: Multiple-dose Pharmacokinetics of Ceftaroline during continuous and intermittent renal replacement therapy in patients requiring renal replacement therapy
    Medical condition: Bacterial infection in patients recieving renal replacement therapy
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000598-41 Sponsor Protocol Number: P903-08 A4 Start Date*: 2007-11-22
    Sponsor Name:Cerexa, Inc.
    Full Title: "A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline versus Ceftriaxone, with Adjunctive Clarithromycin, in the Treatment of Adult...
    Medical condition: Adults Subjects with Community-Acquired Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) AT (Completed) LT (Completed) EE (Completed) SK (Completed) BG (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-000599-18 Sponsor Protocol Number: P903-09 Start Date*: 2008-03-25
    Sponsor Name:Cerexa, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Safety and Efficacy of Ceftaroline versus Ceftriaxone in the Treatment of Adult Subjects with Community-Acquired ...
    Medical condition: Adult Subjects with Community-Acquired Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) DE (Completed) HU (Completed) AT (Completed) LV (Completed)
    Trial results: View results
    EudraCT Number: 2015-002340-14 Sponsor Protocol Number: REMAP-CAP Start Date*: 2015-09-16
    Sponsor Name:University Medical Center Utrecht
    Full Title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP). (COVID-19)
    Medical condition: Severe Community Acquired Pneumonia COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IE (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Completed) BE (Trial now transitioned) DE (Ongoing) HR (Trial now transitioned) ES (Temporarily Halted) FR (Trial now transitioned) FI (Ongoing) IT (Trial now transitioned) CZ (Trial now transitioned) SI (Trial now transitioned) RO (Trial now transitioned)
    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)
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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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