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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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    • 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 2 of 4.
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    EudraCT Number: 2008-004764-39 Sponsor Protocol Number: CTBM100C2303E1 Start Date*: 2009-09-07
    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) Subjects Who Comp...
    Medical condition: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 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: 2012-001541-40 Sponsor Protocol Number: Pro12/15 Start Date*: 2012-08-20
    Sponsor Name:Vu University Medical Center
    Full Title: Effect of Carbon Dioxide Enriched Ambient Air on Pharmacokinetics and Deposition In Bronchiectasis Patients Using Tobramycin Inhalation: A proof of concept study.
    Medical condition: Bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006446 Bronchiectasis NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-000164-17 Sponsor Protocol Number: tobra nasal CF pilot Start Date*: 2008-08-13
    Sponsor Name:University of Jena
    Full Title: Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich. Nasal inhalation of tobramycin by the Pari ...
    Medical condition: subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004416-35 Sponsor Protocol Number: OFT-EDE-2016 Start Date*: 2017-04-21
    Sponsor Name:Fundació Parc Taulí
    Full Title: Efficacy and safety of three regimens based on tobramycin, dexamethasone and diclofenac for the prevention of pseudophakic macular edema. Randomized clinical trial
    Medical condition: Pseudophakic macular edema is a pathology that results from cataract surgery, usually occurring 4-6 weeks after surgery, which directly affects the retina (specifically the macula, the region that ...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004853 10051240 Cystoid macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001406-17 Sponsor Protocol Number: 48009 Start Date*: 2015-01-21
    Sponsor Name:Erasmus MC
    Full Title: Ventilator Associated Pneumonia: addition of Tobramycin Inhalation antibiotic treatment to standard IV antibiotic treatment
    Medical condition: ICU patients with ventilator-associated pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-003621-21 Sponsor Protocol Number: CTBM100DDE04T Start Date*: 2013-10-09
    Sponsor Name:Charité University Hospital Berlin
    Full Title: Prospective phase IIA multicenter double-blinded randomized placebo-controlled clinical trial evaluating the efficacy and safety of inhaled, aerosolized Tobramycin (TOBI®) b.i.d. in patients with v...
    Medical condition: Intensive care unit patients with ventilation-associated pneumonia.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-001401-41 Sponsor Protocol Number: TAPAS-2014 Start Date*: 2014-07-29
    Sponsor Name:
    Full Title: Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis
    Medical condition: Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-003772-37 Sponsor Protocol Number: CTBM100C2302 Start Date*: 2006-01-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects
    Medical condition: Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    10011762
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IT (Completed) HU (Completed) GR (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2011-002000-32 Sponsor Protocol Number: CTBM100C2401 Start Date*: 2011-11-25
    Sponsor Name:Novartis Pharma Services AG
    Full Title: 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: Pseudomonas aeruginosa infection in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10021860 Infection pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) FR (Ongoing) ES (Completed) DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-014042-28 Sponsor Protocol Number: Start Date*: 2009-10-16
    Sponsor Name:Imperial College, London
    Full Title: What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa?
    Medical condition: Cystic Fibrosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-001708-14 Sponsor Protocol Number: ABOGRAFT-01 Start Date*: 2021-06-29
    Sponsor Name:Region Östergötland
    Full Title: Antibiotic Impregnated Bone Graft to reduce infection in hip replacement. The ABOGRAFT trial
    Medical condition: Patients scheduled for any type of hip arthroplasty requiring bone grafting
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-006215-68 Sponsor Protocol Number: CMA-0631-PR-0010 Start Date*: 2008-07-29
    Sponsor Name:Chiesi Farmaceutici S.p.A
    Full Title: A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS...
    Medical condition: cystic fibrosis and P. aeruginosa chronic infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10057582 Lung infection pseudomonal LLT
    9.1 10011763 Cystic fibrosis lung LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) ES (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-004318-82 Sponsor Protocol Number: CTBM100CUS03 Start Date*: 2017-05-15
    Sponsor Name:Novartis Pharmaceuticals Corporation
    Full Title: Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    20.0 100000004862 10021860 Infection Pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001565-33 Sponsor Protocol Number: CTBM100C2403 Start Date*: 2013-06-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment...
    Medical condition: Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    17.1 100000004862 10021860 Infection Pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003177-34 Sponsor Protocol Number: CHDR1722 Start Date*: 2017-12-20
    Sponsor Name:Centre for Human Drug Research
    Full Title: A clinical study to assess the feasibility of measuring inhaled medication concentrations in exhaled breath condensate obtained from healthy volunteers and asthma patients and to assess the relatio...
    Medical condition: Asthma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003553 Asthma PT
    Population Age: Adults Gender: Male
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-003040-39 Sponsor Protocol Number: CTBM100G2202 Start Date*: 2016-09-29
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cysti...
    Medical condition: Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    19.0 10021881 - Infections and infestations 10070295 Infective exacerbation of bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) BE (Completed) DE (Completed) IE (Completed) NL (Completed) GB (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000286-36 Sponsor Protocol Number: LEVODESA_04-2017 Start Date*: 2018-08-28
    Sponsor Name:NTC s.r.l.
    Full Title: An international, multicenter, randomized, blinded-assessor, parallel-group clinical study comparing eye drops of combined LEvofloxAcin + DExamethasone foR 7 days followed by dexamethasone alone fo...
    Medical condition: Prevention and treatment of inflammation and prevention of infection associated with cataract surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 10015919 - Eye disorders 10007739 Cataract PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002211-28 Sponsor Protocol Number: 36713 Start Date*: 2012-11-07
    Sponsor Name:VU medical center
    Full Title: Perioperative selective decontamination of the digestive tract (SDD) in elective colorectal cancer patients: a multicenter randomized clinical trial
    Medical condition: Post-operative infective complications and long term oncological outcome in patients undergoing surgery for colorectal cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10059428 Postoperative infection LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061451 Colorectal cancer PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001204-21 Sponsor Protocol Number: CTBM100CDE02 Start Date*: 2014-11-17
    Sponsor Name:Novartis Pharma GmbH
    Full Title: An 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients ≥ 6 years of age, chronically infected with Ps...
    Medical condition: Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    18.0 100000004862 10021860 Infection Pseudomonas aeruginosa LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-001840-83 Sponsor Protocol Number: SAGA Start Date*: 2022-04-26
    Sponsor Name:University Medical Center Utrecht
    Full Title: Short-course aminoglycosides as adjunctive treatment in adults with sepsis
    Medical condition: Patients admitted with sepsis of unknown origin, suspected urinary origin or suspected abdominal origin
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
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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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