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Clinical trials for Amikacin

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    35 result(s) found for: Amikacin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2008-000248-15 Sponsor Protocol Number: Dartagnan3 Start Date*: 2008-08-01
    Sponsor Name:Association pour la promotion de la réanimation médicale à Tours
    Full Title: Amikacine nébulisée à forte dose. Pharmacocinétique dans la pneumonie associée à la ventilation mécanique D’ARTAGNAN 3
    Medical condition: Ventilator associated pneumonia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-000060-16 Sponsor Protocol Number: AMIK-04-02 Start Date*: 2005-05-06
    Sponsor Name:Aerogen, Inc.
    Full Title: A Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Dose-Ranging Study of Nebulized Amikacin Delivered Via the Pulmonary Drug Delivery System (PDDS) in Patients With Ventilator-Associated Pn...
    Medical condition: Ventilator associated pneumonia (VAP) caused by gram negative organisms.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2005-004899-21 Sponsor Protocol Number: TR02-104 Start Date*: 2005-12-22
    Sponsor Name:Transave, Inc.
    Full Title: Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa.
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-004389-17 Sponsor Protocol Number: TR02-103 Start Date*: 2005-12-28
    Sponsor Name:Transave, Inc
    Full Title: SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA
    Medical condition: Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-003972-64 Sponsor Protocol Number: 2015-09 Start Date*: 2019-07-02
    Sponsor Name:ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
    Full Title: Plasma and tissue pharmacokinetics of amikacin administrated by dressing impregnated in burns patients
    Medical condition: burns patients
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-005079-17 Sponsor Protocol Number: 06-IN-AK004 Start Date*: 2007-02-19
    Sponsor Name:Nektar Therapeutics
    Full Title: An Open-Label, Multicenter, Multinational Study to Assess the Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-Ventilated Patients with Nosocomial Pne...
    Medical condition: Nosocomial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    8.1 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-001054-17 Sponsor Protocol Number: PHRN15-SE/AMIKINHAL Start Date*: 2017-01-27
    Sponsor Name:CHRU de Tours
    Full Title: Double-blinded multicenter randomized controlled trial comparing inhaled amikacin versus placebo to prevent ventilator associated pneumonia
    Medical condition: Patient with mechanical ventilation through an endotracheal tube
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002855-13 Sponsor Protocol Number: CAP-01-102 Start Date*: 2014-02-14
    Sponsor Name:Cardeas Pharma
    Full Title: A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered via the Investigational eFlow® Inline System in Mechanically Ventilated...
    Medical condition: Gram-negative Bacterial Pneumonia in Mechanically Ventilated Patients
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) GR (Completed) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-001296-32 Sponsor Protocol Number: FC/HULP-2014_01 Start Date*: 2014-07-07
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Universitario de La Paz
    Full Title: Pharmacokinetic and pharmacodynamic optimization of amikacin treatment in patients with terminal renal failure under conventional hemodialysis: randomized clinical trial of two model of administration
    Medical condition: Terminal renal failure under hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038359 - Renal and urinary disorders 10038444 Renal failure chronic PT
    17.0 10038359 - Renal and urinary disorders 10014647 End stage renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-006980-22 Sponsor Protocol Number: TR02-105 Start Date*: 2007-06-14
    Sponsor Name:Transave, Inc.
    Full Title: MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011762 Cystic fibrosis LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed) BE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2018-003496-36 Sponsor Protocol Number: 69HCL17_0843 Start Date*: 2019-11-06
    Sponsor Name:Hospices Civils de Lyon
    Full Title: Dosage optimization of piperacillin/tazobactam in ICU patients based on therapeutic drug monitoring of amikacin - OPTIMA
    Medical condition: sepsis or septic shock
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10040047 Sepsis PT
    20.0 10021881 - Infections and infestations 10040070 Septic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000442-38 Sponsor Protocol Number: TR02-109 Start Date*: 2011-10-03
    Sponsor Name:Insmed Incorporated
    Full Title: Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aer...
    Medical condition: Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended) PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2020-003079-16 Sponsor Protocol Number: INS-416 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ENCORE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of an Amikacin Liposome Inhalation Suspension (ALIS)-Based Regimen ...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    22.1 10021881 - Infections and infestations 10061229 Lung infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) FR (Trial now transitioned) DE (Ongoing) AT (Trial now transitioned) HU (Completed) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-005627-21 Sponsor Protocol Number: APHP211043 Start Date*: 2022-08-31
    Sponsor Name:APHP
    Full Title: 3-day intravenous antibiotic treatment versus 3-day intravenous followed by 7-day oral antibiotic treatment for acute pyelonephritis in children 1 month to 3 years old: a non-inferiority open rando...
    Medical condition: Acute pyelonephritis in children 1 month to 3 years old
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-000441-20 Sponsor Protocol Number: TR02-108 Start Date*: 2011-06-29
    Sponsor Name:Insmed Incorporated
    Full Title: Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aerug...
    Medical condition: Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) BE (Completed) IE (Completed) DE (Completed) AT (Completed) GR (Completed) NL (Completed) DK (Completed) ES (Completed) IT (Completed) BG (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2013-001048-73 Sponsor Protocol Number: BAY41-6551/13084 Start Date*: 2013-07-25
    Sponsor Name:Bayer AG
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati...
    Medical condition: Gram-negative pneumonia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10035701 Pneumonia gram-negative bacterial NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2020-002545-42 Sponsor Protocol Number: INS-415 Start Date*: 2021-02-08
    Sponsor Name:Insmed Incorporated
    Full Title: ARISE - A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, Multicenter Study to Validate Patient-Reported Outcome Instruments in Adult Subjects with Newly Diagnosed Nontuberculous M...
    Medical condition: Adult Subjects with Newly Diagnosed Nontuberculous Mycobacterial (NTM) Lung Infection Caused by Mycobacterium avium Complex (MAC)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) DE (Completed) HU (Completed) AT (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-007940-92 Sponsor Protocol Number: TR02-107 Start Date*: 2008-12-12
    Sponsor Name:Transave, Inc.
    Full Title: A PLACEBO CONTROLLED, RANDOMIZED, PARALLEL COHORT, SAFETY AND TOLERABILITY STUDY OF TWO DOSE LEVELS OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN PATIENTS WITH BRONCHIECTASIS COMPLICATED BY CH...
    Medical condition: Bronchiectasis Complicated by Chronic Infection due to Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006445 Bronchiectasis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) BE (Completed) HU (Completed) GR (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-003170-33 Sponsor Protocol Number: INS-312 Start Date*: 2016-03-14
    Sponsor Name:Insmed Inc.
    Full Title: An Open-Label Safety Extension Study to a Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacter...
    Medical condition: Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10058806 Mycobacterium avium complex infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) AT (Completed) ES (Completed) PL (Completed) NL (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-005010-31 Sponsor Protocol Number: INS-212 Start Date*: 2015-07-03
    Sponsor Name:Insmed Inc.
    Full Title: A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections Caused by Mycobacterium avium comple...
    Medical condition: Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10058806 Mycobacterium avium complex infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed) NL (Completed) ES (Completed) PL (Completed) SE (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
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