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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
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    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 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2013-004488-30 Sponsor Protocol Number: TAPAS-PK-2014 Start Date*: 2014-01-31
    Sponsor Name:Haga Hospital
    Full Title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK)
    Medical condition: Cystic fibrosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005346-20 Sponsor Protocol Number: PA07/8376 Start Date*: 2007-12-04
    Sponsor Name:Leeds Teaching Hospitals NHS Trust
    Full Title: Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis?
    Medical condition: Children with cystic fibrosis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-000959-33 Sponsor Protocol Number: CTP G007.04 Start Date*: 2007-08-16
    Sponsor Name:PARI GmbH
    Full Title: Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF
    Medical condition: Cystic Fibrosis with Pseudomonas aeruginosa infection
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005014-21 Sponsor Protocol Number: DPI-tobra-kind Start Date*: Information not available in EudraCT
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis
    Medical condition: Cystic Fibrosis Lung infections
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023030-23 Sponsor Protocol Number: 10076 Start Date*: 2010-12-24
    Sponsor Name:The Univeristy of Nottingham [...]
    1. The Univeristy of Nottingham
    2.
    Full Title: Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF
    Medical condition: Cystic fibrosis
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-001109-15 Sponsor Protocol Number: BIOTOB Start Date*: 2015-12-15
    Sponsor Name:INSTITUTO DE INVESTIGACION SANITARIA LA FE
    Full Title: A Phase III clinical trial randomized and blinded on the use of inhaled tobramycin compared with placebo in patients undergoing mechanical ventilation and colonized by Gram negative bacteria for ef...
    Medical condition: critically ill patients undergoing mechanical ventilation
    Disease: Version SOC Term Classification Code Term Level
    18.1 10022117 - Injury, poisoning and procedural complications 10066821 Mechanical ventilation complication PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-004437-16 Sponsor Protocol Number: tobra-02 Start Date*: 2013-05-15
    Sponsor Name:University Medical Center Groningen
    Full Title: Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis
    Medical condition: Bronchiectasis Lung infections
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-005110-41 Sponsor Protocol Number: 9999999999999999999 Start Date*: 2008-12-09
    Sponsor Name:not applicable
    Full Title: Circadian Influence on Renal Clearance of Aminoglycosides in cystic fibrosis patients
    Medical condition: Repeated or extended dosing of aminoglycosides may cause damage to the proximal tubuli, resulting in renal impairment. Renal impairment affects up to 40 % of adult CF patients, measured after estim...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004103-10 Sponsor Protocol Number: CTP-G007.05, Protocol Amendment 02 Start Date*: 2006-05-03
    Sponsor Name:PARI Pharma GmbH
    Full Title: Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in...
    Medical condition: Cystic Fibrosis with Pseudomoas aeuriginosa infection
    Disease: Version SOC Term Classification Code Term Level
    8.1 10011763 Cystic fibrosis lung LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) PL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003868-22 Sponsor Protocol Number: RM/NEB/01-07 Start Date*: 2008-03-19
    Sponsor Name:Laboratoire Erempharma
    Full Title: ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION.
    Medical condition: Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutic...
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023235-41 Sponsor Protocol Number: 12012.101 Start Date*: Information not available in EudraCT
    Sponsor Name:PARI Pharma GmbH
    Full Title: A comparative, randomised, two period, multi-center, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chr...
    Medical condition: Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection
    Disease: Version SOC Term Classification Code Term Level
    12.1 10011763 Cystic fibrosis lung LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-000166-35 Sponsor Protocol Number: 54939 Start Date*: 2016-08-08
    Sponsor Name:Noordwest Ziekenhuisgroep
    Full Title: Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice dai...
    Medical condition: Patients with non-cystic fibrosis bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10070295 Infective exacerbation of bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003882-10 Sponsor Protocol Number: 2014_21 Start Date*: Information not available in EudraCT
    Sponsor Name:CHRU de Lille
    Full Title: Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) asso...
    Medical condition: mucoviscidosis or cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10068288 Cystic fibrosis pulmonary exacerbation LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002503-17 Sponsor Protocol Number: TONI-2012 Start Date*: 2012-12-21
    Sponsor Name:Erasmus University Medical Centre
    Full Title: Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002387-32 Sponsor Protocol Number: UoL001019 Start Date*: 2014-08-05
    Sponsor Name:University of Liverpool
    Full Title: Phase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis
    Medical condition: Aminoglycoside-induced nephrotoxicity
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    18.0 10022891 - Investigations 10069022 Kidney injury molecule-1 PT
    18.0 100000004857 10067571 Nephrotoxicity LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-002318-22 Sponsor Protocol Number: CTBM100C2303 Start Date*: 2009-09-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a ...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    9.1 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) EE (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2015-004814-84 Sponsor Protocol Number: CS/2016/01 Start Date*: 2016-05-18
    Sponsor Name:Sint Antonius Hospital
    Full Title: Individualized dosing of aminoglycosides, quinolones and glycopeptide antibiotics in (morbidly) obese patients
    Medical condition: Morbid obesity
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-004507-36 Sponsor Protocol Number: CTBM100DDE01 Start Date*: 2008-08-19
    Sponsor Name:Novartis Pharma GmbH
    Full Title: A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cyst...
    Medical condition: patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    9.1 10011763 Cystic fibrosis lung LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-000923-15 Sponsor Protocol Number: THILO08 Start Date*: 2013-05-24
    Sponsor Name:FARMEX SA
    Full Title: A multicenter, double-blind, randomized, parallel arm comparative study for the assessment of the safety and efficacy of azidamfenicol eye drops (Thilocof®/FARMEX) versus tobramycine eye drops (Τob...
    Medical condition: Infections of the outer eye layers (mainly bacterial conjuctivitis )
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10010742 Conjunctivitis infective PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016734-26 Sponsor Protocol Number: CTBM100C2303E2 Start Date*: 2010-01-08
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who succ...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    12.0 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: EE (Completed) LV (Completed) LT (Completed) BG (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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