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Clinical trials for Ceftobiprole medocaril

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
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    • 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 ).  
     
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    12 result(s) found for: Ceftobiprole medocaril. Displaying page 1 of 1.
    EudraCT Number: 2013-004614-18 Sponsor Protocol Number: BPR-PIP-001 Start Date*: 2014-07-30
    Sponsor Name:Basilea Pharmaceutica International Ltd.
    Full Title: An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Ceftobiprole in Neonate and Infant Subjects Aged ≤ 3 Months Undergoing Treatment with Systemic Antibiotics
    Medical condition: documented or presumed bacterial infections, or at risk of a bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10010120 Community acquired pneumonia LLT
    21.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BE (Prematurely Ended) DE (Prematurely Ended) LT (Prematurely Ended) PL (Prematurely Ended) LV (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-001837-35 Sponsor Protocol Number: BPR-PIP-003 Start Date*: 2023-02-27
    Sponsor Name:Basilea Pharmaceutica International Ltd, Allschwil
    Full Title: A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety, pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-term neonates and infants up to 3 months ...
    Medical condition: Late-onset sepsis (LOS) in term and pre-term neonates and infants up to 3 months of age.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) LV (Prematurely Ended) SK (Completed) PL (Completed) Outside EU/EEA EE (Completed) BG (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-003917-83 Sponsor Protocol Number: CHAVANET-BASILEA-2016 Start Date*: 2017-08-16
    Sponsor Name:CHU de DIJON
    Full Title: Open and exploratory trial to investigate the pharmacokinetic of ceftobiprole medocaril in patients with CSF device
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027199 Meningitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-004615-45 Sponsor Protocol Number: BPR-PIP-002 Start Date*: 2016-12-02
    Sponsor Name:Basilea Pharmaceutica International Ltd
    Full Title: A multicentre, randomized, investigator-blind, active-controlled study to evaluate the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole versus intravenous standard-of-care cephal...
    Medical condition: Hospital-acquired pneumonia or community-acquired pneumonia requiring hospitalisation.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10010120 Community acquired pneumonia LLT
    19.0 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-003464-22 Sponsor Protocol Number: CEFTOFBN3004 Start Date*: 2007-10-05
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Noninferiority, Multicenter Study of Ceftobiprole Medocaril Versus Cefepime With or Without Vancomycin in the Treatment of Subjects Wi...
    Medical condition: Subjects 18 years of age or older with fever and neutropenia after chemotherapy for cancer, who require i.v. therapy for treatment of fever and neutropenia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) HU (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-001730-17 Sponsor Protocol Number: BAP00248/307 Start Date*: 2004-09-16
    Sponsor Name:Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Full Title: A Phase 3, Randomized Double-Blind Study of Ceftobiprole Medocaril Versus Linezolid Plus Ceftazidime in the Treatment of Nosocomial Pneumonia
    Medical condition: Nosocomial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) HU (Completed) GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-002301-23 Sponsor Protocol Number: BAP00414 Start Date*: 2005-12-14
    Sponsor Name:Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
    Full Title: A Phase 3, Randomized, Double-Blind Study Of Ceftobiprole Medocaril Versus Vancomycin With Ceftazidime in The Treatment Of Complicated Skin And Skin Structure Infections
    Medical condition: complicated skin and skin structure infection
    Disease: Version SOC Term Classification Code Term Level
    5.1 10040786 HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LV (Completed) LT (Completed) EE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-001662-41 Sponsor Protocol Number: BAP00154 Start Date*: 2004-09-16
    Sponsor Name:Basilea Pharmaceutica Ltd
    Full Title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole versus Vancomycin in the Treatment of Complicated Skin and Skin Structure Infections
    Medical condition: Complicated skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    LLT 10024768 code
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-000835-84 Sponsor Protocol Number: 30982081-CAP-3001 Start Date*: 2006-10-10
    Sponsor Name:Jansen-Cilag International N.V.
    Full Title: Randomized, Double-Blind, Multicenter Study of Ceftobiprole Medocaril Versus Ceftriaxone with/without Linezolid in Treatment of Subjects Hospitalized With Community-Acquired Pneumonia
    Medical condition: Hospitalized community acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) LT (Completed) HU (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2017-001699-43 Sponsor Protocol Number: BPR-CS-009 Start Date*: 2018-12-13
    Sponsor Name:Basilea Pharmaceutica International Ltd
    Full Title: A randomized, double-blind, multi-center study to establish the efficacy and safety of ceftobiprole medocaril compared to daptomycin in the treatment of Staphylococcus aureus bacteremia, including ...
    Medical condition: Complicated staphylococcus aureus bacteremia (cSAB)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10058887 Staphylococcus aureus bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) BG (Completed) ES (Completed) IT (Completed) GR (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001605-32 Sponsor Protocol Number: BPR-CS-008 Start Date*: 2017-10-06
    Sponsor Name:Basilea Pharmaceutica International Ltd
    Full Title: A randomized, double-blind, multicenter study to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and ski...
    Medical condition: Acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2005-004174-24 Sponsor Protocol Number: BAP00248 Start Date*: 2006-08-24
    Sponsor Name:Johnson&Johnson Pharmaceutical Research&Development, L.L.C.
    Full Title: A Phase 3 Randomized, Double-Blind Study of Ceftobiprole Medocaril versus Linezolid Plus Ceftazidime in the Treatment of Nosocomial Pneumonia
    Medical condition: Hospital-Acquired or Nosocomial Pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    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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