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Clinical trials for Tobramycin

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    78 result(s) found for: Tobramycin. Displaying page 3 of 4.
    EudraCT Number: 2011-001821-26 Sponsor Protocol Number: SP2 Start Date*: 2011-10-18
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity
    Medical condition: Adult patient with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003532-23 Sponsor Protocol Number: CTBM100C2401E1 Start Date*: 2012-12-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
    Medical condition: Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    14.1 100000004862 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) IT (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-006502-42 Sponsor Protocol Number: #FFC17/2007 Start Date*: 2008-04-22
    Sponsor Name:AZIENDA OSPEDALIERA MEYER
    Full Title: Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038738 SOC
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2006-002933-18 Sponsor Protocol Number: COPDIT Start Date*: 2007-11-05
    Sponsor Name:InfectoPharm Arzneimittel und Consilium GmbH
    Full Title: Multizentrische, randomisierte, doppelblinde, placebokontrollierte Phase III-Studie zur (Langzeit-) Add On-Behandlung der COPD (Schweregrad III/IV) mit 2 x 80 mg inhalativem Tobramycin (Gernebcin)
    Medical condition: Austherapierte schwere bis sehr schwere COPD (Schweregrad III-IV) mit mindestens 2 COPD-Exazerbations-bedingten Hospitalisationen innerhalb der letzten 12 Monate
    Disease: Version SOC Term Classification Code Term Level
    9.1 10010952 COPD LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-003628-39 Sponsor Protocol Number: TNS0107 Start Date*: 2007-11-22
    Sponsor Name:ECUPHARMA S.R.L.
    Full Title: Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, i...
    Medical condition: Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10024970 Respiratory tract infections HLGT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-002035-28 Sponsor Protocol Number: TBM100C2301 (TIP002) Start Date*: 2005-09-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects
    Medical condition: pulmonary P aeruginosa infection in patient with 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: LT (Completed)
    Trial results: View results
    EudraCT Number: 2010-019634-26 Sponsor Protocol Number: MPEX-209 Start Date*: 2011-05-24
    Sponsor Name:Mpex Pharmaceuticals, Inc.
    Full Title: A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients
    Medical condition: Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    14.0 10021881 - Infections and infestations 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) FR (Ongoing) IE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004277-26 Sponsor Protocol Number: GS-US-205-0110 Start Date*: 2008-04-29
    Sponsor Name:Gilead Sciences Inc
    Full Title: An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Int...
    Medical condition: Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
    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: BE (Completed) FR (Completed) ES (Completed) GB (Completed) IE (Completed) DK (Completed) DE (Completed) NL (Completed) IT (Completed) PT (Completed) AT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-016590-15 Sponsor Protocol Number: CTBM100C2304 Start Date*: 2009-12-29
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infection...
    Medical condition: Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    14.1 100000004862 10068292 Pseudomonas colonization LLT
    14.1 100000004862 10068297 Pseudomonas colonisation LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) FR (Completed) GR (Completed) DE (Completed) IT (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-006171-19 Sponsor Protocol Number: 2011 Start Date*: 2011-10-27
    Sponsor Name:AZIENDA OSPEDALIERA MEYER
    Full Title: randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old.
    Medical condition: Cystic fibrosis patients with early P.aeruginosa infection.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10038738 Respiratory, thoracic and mediastinal disorders SOC
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004211-30 Sponsor Protocol Number: 2005-23 Start Date*: 2005-10-17
    Sponsor Name:The Norwegian Radium Hospital
    Full Title: Penicillin G and an aminoglycoside versus meropenem as initial empiric antibiotic therapy in lymphoma and leukemia patients with febrile neutropenia
    Medical condition: Lymphoma and leukemia patients with febrile neutropenia
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-004417-16 Sponsor Protocol Number: 5022LC Start Date*: Information not available in EudraCT
    Sponsor Name:St. Elisabeth Hospital
    Full Title: CEFTRIAXONE NEONATAL THERAPY: A RANDOMIZED CONTROLLED TRIAL TO EVALUATE THE EFFECT OF CEFTRIAXONE ON HYPERBILIRUBINEMIA
    Medical condition: Hyperbilirubinemia
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    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: 2009-012575-10 Sponsor Protocol Number: CH/2007/2661 Start Date*: 2009-11-16
    Sponsor Name:University Hospitals Bristol NHS Foundation Trust [...]
    1. University Hospitals Bristol NHS Foundation Trust
    2. University of Liverpool
    Full Title: Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis
    Medical condition:
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-004297-14 Sponsor Protocol Number: SLH2015001 Start Date*: 2016-06-08
    Sponsor Name:Streeklaboratorium voor de volksgezondheid Kennemerland
    Full Title: Effectiveness of fosfomycin versus nitrofurantoin in Dutch risk groups with cystitis: a pilot study (Uri-weg study)
    Medical condition: Cystitis without tissue invasion (uncomplicated cytitis)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-003675-36 Sponsor Protocol Number: COLO/DPI/02/06 Start Date*: 2005-04-28
    Sponsor Name:Forest Laboratories UK Ltd
    Full Title: A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOB...
    Medical condition: Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) AT (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-003483-46 Sponsor Protocol Number: 10-0060+EU-Appendix5.0,11.12.2014 Start Date*: 2013-11-12
    Sponsor Name:University of Florida Board of Trustees
    Full Title: Impact of Aggressive Empiric Antibiotic Therapy and Duration of Therapy on the Emergence of Antimicrobial Resistance during the Treatment of Hospitalized Subjects with Pneumonia Requiring Mechanica...
    Medical condition: pneumonia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10060946 Pneumonia bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-000724-40 Sponsor Protocol Number: PTC124-GD-006-CF Start Date*: 2007-09-27
    Sponsor Name:PTC Therapeutics, Inc.
    Full Title: A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis
    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: BE (Completed)
    Trial results: View results
    EudraCT Number: 2013-002066-39 Sponsor Protocol Number: REPEXStudy Start Date*: 2013-09-04
    Sponsor Name:Azienda Ospedaliera di Reggio Emilia Arcispedale "S.Maria Nuova"/IRCCS
    Full Title: The Reggio Emilia study on bromfenac for patients with PseudoEXfoliation syndrome undergoing cataract surgery: the REPEX study
    Medical condition: Postoperative inflammation in patients with pseudoexfoliatio lentis undergoing cataract surgery
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001840-20 Sponsor Protocol Number: CTBM100C2412 Start Date*: 2016-05-18
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Usi...
    Medical condition: cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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