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Clinical trials for Avibactam

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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    22 result(s) found for: Avibactam. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-001416-15 Sponsor Protocol Number: 2019-ANA-01-CAZ-AVI Start Date*: 2021-03-09
    Sponsor Name:Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
    Full Title: Pharmacokinetics of Ceftazidime-Avibactam in Bile Fluid – an in-vivo Study
    Medical condition: N/A => Pharmacokinetic study
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-002742-68 Sponsor Protocol Number: C3601002 Start Date*: 2018-04-24
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 3 Prospective, Randomized, Multicenter, Open-Label, Central Assessor-Blinded, Parallel Group, Comparative Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (AT...
    Medical condition: Complicated intra-abdominal infection (cIAI) and hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Ongoing) BG (Completed) GR (Completed) HR (Completed) IT (Completed) RO (Ongoing)
    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: 2012-004006-96 Sponsor Protocol Number: D4281C00001 Start Date*: 2012-12-27
    Sponsor Name:Astrazeneca AB
    Full Title: A Phase III, Randomized, Multicentre, Double-blind, Double-dummy, Parallel-group Comparative Study to Determine the Efficacy, Safety And Tolerability of Ceftazidime-Avibactam Versus Meropenem in th...
    Medical condition: nosocomial pneumonia (NP), ventilator-associated pneumonia (VAP)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) GB (Completed) ES (Completed) IT (Prematurely Ended) PL (Completed) BG (Completed) LV (Completed) SI (Completed) LT (Prematurely Ended) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2013-001900-13 Sponsor Protocol Number: D4280C00014 Start Date*: 2013-06-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase I Study to Assess the Pharmacokinetics, Safety and Tolerability of a Single Dose of Ceftazidime-Avibactam (CAZ-AVI) in Children From 3 Months of Age to <18 Years Who Are Receiving Systemic ...
    Medical condition: hospitalized pediatric patients receiving systemic antibiotic therapy for suspected or confirmed infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10021804 Infection bacterial LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005721-43 Sponsor Protocol Number: D4280C00002 Start Date*: 2012-05-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly C...
    Medical condition: Complicated Urinary Tract Infections (cUTIs)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) BE (Completed) BG (Completed) DE (Completed) CZ (Completed) SK (Completed) PT (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2011-005722-21 Sponsor Protocol Number: D4280C00004 Start Date*: 2012-06-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI, formerly C...
    Medical condition: Complicated Urinary Tract Infections (cUTIs)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) DE (Completed) CZ (Completed) ES (Completed) IT (Completed) BG (Completed) PL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-004544-38 Sponsor Protocol Number: C3601009 Start Date*: 2020-07-03
    Sponsor Name:Pfizer Inc.
    Full Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INF...
    Medical condition: SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021804 Infection bacterial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2012-000726-21 Sponsor Protocol Number: D4280C00006 Start Date*: 2012-09-11
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Randomized, Multicenter, Phase III Study of Ceftazidime Avibactam (CAZ-AVI, formerly CAZ104) and Best Available Therapy for the Treatment of Infections Due to Ceftazidime Resistant G...
    Medical condition: cUTI, Complicated Urinary Tract Infection, cIAI, Complicated intra-abdominal infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10046574 Urinary tract infection NOS LLT
    14.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) CZ (Completed) ES (Completed) GR (Completed) BG (Completed) HU (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-003893-97 Sponsor Protocol Number: D4280C00001 Start Date*: 2011-12-14
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Multicenter, Double-Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime-Avibactam (CAZ-AVI) Plus Metr...
    Medical condition: Complicated Intra-Abdominal Infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) PT (Completed) ES (Completed) HU (Completed) BG (Completed) SK (Completed) NL (Completed) LV (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2011-003895-35 Sponsor Protocol Number: D4280C00005 Start Date*: 2012-04-11
    Sponsor Name:AstraZeneca AB
    Full Title: A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole V...
    Medical condition: Complicated Intra-Abdominal Infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) CZ (Completed) GR (Completed) ES (Completed) BG (Completed) IT (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003242-28 Sponsor Protocol Number: D4280C00015 Start Date*: 2015-05-20
    Sponsor Name:AstraZeneca AB
    Full Title: A single blind, randomised, multi-centre, active controlled, trial to evaluate safety, tolerability, pharmacokinetics and efficacy of ceftazidime and avibactam when given in combination with metron...
    Medical condition: Complicated Intra-Abdominal Infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) CZ (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-003244-13 Sponsor Protocol Number: D4280C00016 Start Date*: 2015-04-17
    Sponsor Name:Pfizer Inc.
    Full Title: A single blind, randomised, multi-centre, active controlled, trial to evaluate safety, tolerability, pharmacokinetics and efficacy of ceftazidime and avibactam compared with cefepime in children fr...
    Medical condition: Complicated urinary tract infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000005053 10046577 Urinary tract infections HLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) GR (Completed) PL (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2018-002800-16 Sponsor Protocol Number: C3591024 Start Date*: 2019-12-10
    Sponsor Name:Pfizer Inc.
    Full Title: A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CEFTAZIDIME AND AVIBACTAM IN NEONATES AND INFANT...
    Medical condition: Infections with suspected or confirmed Gram-negative pathogens
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10032531 Other specified bacterial infections in conditions classified elsewhere and of unspecified site LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SK (Completed) HU (Completed) EE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-002726-39 Sponsor Protocol Number: D4910C00009/C3601001 Start Date*: 2016-02-25
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase IIa prospective, open-label, multicenter study to determine the pharmacokinetics (PK) and safety and tolerability of aztreonam-avibactam (ATM-AVI) for the treatment of complicated Intra-Abd...
    Medical condition: Complicated Intra-Abdominal Infections (cIAIs) in hospitalized adults
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2018-002841-12 Sponsor Protocol Number: C3591025 Start Date*: 2019-12-16
    Sponsor Name:Pfizer Inc.
    Full Title: A Phase 1, Open-Label, Single-Dose Study To Assess The Pharmacokinetics, Safety And Tolerability Of Ceftazidime-Avibactam (Caz-Avi) In Children From 3 Months To Less Than 18 Years Of Age Who Are Ho...
    Medical condition: Suspected Or Confirmed Nosocomial Pneumonia, Including Ventilator-Associated Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (Prematurely Ended) GB (GB - no longer in EU/EEA) EE (Prematurely Ended) GR (Prematurely Ended) NL (Ongoing) IT (Prematurely Ended)
    Trial results: View results
    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: 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: 2017-002110-32 Sponsor Protocol Number: 10-0065 Start Date*: 2018-06-13
    Sponsor Name:Regents of the University of Michigan
    Full Title: DMID Protocol Number: 10-0065 OVERCOME Trial: Randomized Controlled Trial for the Treatment of Extensively Drug-Resistant Gram-negative Bacilli
    Medical condition: Blood stream Infection (BSI) and/or pneumonia due to extensively drug-resistant Gram-negative bacilli (XDR-GNB) including XDR-AB, CRE and XDR-PA
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    20.1 10021881 - Infections and infestations 10035701 Pneumonia gram-negative bacterial NOS LLT
    20.1 10021881 - Infections and infestations 10064977 Acinetobacter bacteremia LLT
    20.0 10021881 - Infections and infestations 10051190 Pneumonia Pseudomonas aeruginosa LLT
    20.0 10021881 - Infections and infestations 10035679 Pneumonia due to Escherichia coli (E. Coli) LLT
    20.0 10021881 - Infections and infestations 10054280 Escherichia coli bacteraemia LLT
    20.0 10021881 - Infections and infestations 10021860 Infection Pseudomonas aeruginosa LLT
    20.1 10021881 - Infections and infestations 10023456 Klebsiella pneumonia LLT
    20.0 10021881 - Infections and infestations 10058883 Klebsiella bacteremia LLT
    20.0 10021881 - Infections and infestations 10054218 Enterobacter pneumonia PT
    20.1 10021881 - Infections and infestations 10058884 Enterobacter bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Completed) GR (Completed) IT (Completed)
    Trial results: (No results available)
    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)
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