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Clinical trials for Ceftolozane

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   44341   clinical trials with a EudraCT protocol, of which   7370   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.
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    11 result(s) found for: Ceftolozane. Displaying page 1 of 1.
    EudraCT Number: 2014-003485-24 Sponsor Protocol Number: CXA-PEDS-13-08 Start Date*: 2014-09-25
    Sponsor Name:Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic ...
    Medical condition: This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    20.0 100000004865 10049086 Antibacterial prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-000059-42 Sponsor Protocol Number: 31/17/0334 Start Date*: 2018-07-25
    Sponsor Name:CHU DE TOULOUSE
    Full Title: Comparison of short infusion versus prolonged infusion of ceftolozane-tazobactam among patients with ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units
    Medical condition: Ventilator associated-pneumonia to Pseudomonas aeruginosa in intensive care units
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004704-19 Sponsor Protocol Number: MK-7625A-036 Start Date*: 2019-08-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc
    Full Title: A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nos...
    Medical condition: Nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Trial now transitioned) EE (Trial now transitioned) Outside EU/EEA GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-002862-11 Sponsor Protocol Number: CXA-NP-11-04 Start Date*: 2015-07-27
    Sponsor Name:Cubist Pharmaceuticals GmbH
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter, Phase 3 Study to Assess the Safety and Efficacy of Intravenous Ceftolozane/tazobactam Compared With Meropenem in Adult Patients with Ventilated...
    Medical condition: Ventilated Nosocomial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) EE (Completed) DE (Completed) BE (Completed) LV (Completed) CZ (Completed) HU (Completed) SK (Completed) AT (Completed) GR (Completed) PT (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004820-41 Sponsor Protocol Number: MK-7625A-035 Start Date*: 2017-08-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropen...
    Medical condition: Complicated intra-abdominal infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) ES (Completed) HU (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-006908-32 Sponsor Protocol Number: PNEUMONOVA Start Date*: 2022-07-01
    Sponsor Name:Sonia Luque Pardos
    Full Title: Intrapulmonary penetration of ceftolozane / tazobactam and ceftazidime / avibactam administered in continuous infusion in critically ill patients with nosocomial pneumonia
    Medical condition: Nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004153-32 Sponsor Protocol Number: MK-7625A-034 Start Date*: 2017-07-25
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Sub...
    Medical condition: Treatment of complicated urinary tract infection (cUTI), including pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10037606 Pyelonephritis, unspecified LLT
    20.0 100000004862 10046576 Urinary tract infection, site not specified LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) GR (Completed) Outside EU/EEA RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-002327-15 Sponsor Protocol Number: APHP180596 Start Date*: 2023-03-15
    Sponsor Name:APHP
    Full Title: Beta-lactam Intermittent versus Continuous infusion and Combination antibiotic therapy in Sepsis
    Medical condition: Beta-lactam Intermittent vs Continuous infusion and Combination antibiotic therapy in Sepsis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000492-32 Sponsor Protocol Number: AMIII Start Date*: 2019-01-14
    Sponsor Name:Charité-Universitätsmedizin Berlin
    Full Title: Effects of antibiotics on micobiota, pulmonary immune response and incidence of ventilator-associated infections
    Medical condition: mechanically ventilated patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-003847-10 Sponsor Protocol Number: SHORTENII Start Date*: 2022-01-12
    Sponsor Name:Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI)
    Full Title: Efficacy and safety of 7 versus 14 days of antibiotic treatment for Pseudomonas aeruginosa bacteraemia: a multicentre, randomized clinical trial (SHORTEN-2) with a DOOR/RADAR analysis
    Medical condition: Adult patients with bloodstream infections produced by Pseudomonas aeruginosa.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    22.1 10021881 - Infections and infestations 10037132 Pseudomonal infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023452-87 Sponsor Protocol Number: CXA-cUTI-10-04 Start Date*: 2011-08-11
    Sponsor Name:Cubist Pharmaceuticals, Inc.
    Full Title: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PHASE 3 STUDY TO COMPARE THE SAFETY AND EFFICACY OF INTRAVENOUS CXA 201 AND INTRAVENOUS LEVOFLOXACIN IN COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELO...
    Medical condition: Complicated Urinary Tract Infection, Including Pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) SK (Completed) LV (Completed) EE (Completed) RO (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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