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Clinical trials for Colistimethate

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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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    26 result(s) found for: Colistimethate. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-004558-13 Sponsor Protocol Number: Z7224L02 Start Date*: 2017-05-30
    Sponsor Name:Zambon S.p.A.
    Full Title: A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of sub...
    Medical condition: Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PL (Completed) DE (Completed) PT (Completed) GR (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2007-003092-39 Sponsor Protocol Number: PHARMACOLIS Start Date*: 2007-11-20
    Sponsor Name:CHU DE POITIERS
    Full Title: Pharmacokinetics of colistimethate and colistine after a 60 minutes intravenous infusion of colistimethate 1 million UI (80 mg) in 12 healthy volunteers
    Medical condition: kidney infection genital infection
    Disease: Version SOC Term Classification Code Term Level
    9.1 10023424 Kidney infection LLT
    9.1 10018152 Genital infection bacterial NOS LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000192-13 Sponsor Protocol Number: COLO/DPI/02/11 Start Date*: 2011-04-28
    Sponsor Name:Forest Laboratories UK Ltd.
    Full Title: A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in ...
    Medical condition: cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    13.1 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    13.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-002743-33 Sponsor Protocol Number: Z7224L01 Start Date*: 2017-02-21
    Sponsor Name:Zambon S.p.A.
    Full Title: A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with ...
    Medical condition: Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    21.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Ongoing) DE (Completed) PT (Completed) NL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002269-23 Sponsor Protocol Number: COLELF17 Start Date*: 2018-05-22
    Sponsor Name:AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
    Full Title: PHARMACOKINETICS OF COLISTIN IN THE ELF AND THE PLASMA OF MDR-GNB OR XDR- GNB VAP OR VAT OR HCAP OR HAP PATIENTS WHO ARE MECHANICALLY VENTILATED: A RANDOMIZED CONTROLLED TRIAL
    Medical condition: ventilator associated pneumonia or ventilator associated tracheobronchitis or health-care associated pneumonia or hospital acquired pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10044314 Tracheobronchitis PT
    20.1 10021881 - Infections and infestations 10035701 Pneumonia gram-negative bacterial NOS LLT
    22.0 100000004855 10047263 Ventilation pneumonitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2022-000476-18 Sponsor Protocol Number: SPX-CF-001 Start Date*: 2022-05-24
    Sponsor Name:EnBiotix, Inc.
    Full Title: Tolerability and Safety of Inhaled Colistimethate Sodium Administered Once Daily Compared to Twice Daily Dosing in Adult and Adolescent Subjects with Cystic Fibrosis and Chronic Pseudomonas Aerugin...
    Medical condition: Chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011763 Cystic fibrosis lung PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: HU (Ongoing) SK (Ongoing) PL (Ongoing)
    Trial results: (No results available)
    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: 2015-000066-62 Sponsor Protocol Number: 7655A-013 Start Date*: 2015-08-04
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Im...
    Medical condition: imipenem-resistant bacterial infections, including hospital-associated or ventilator acquired pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinary tract infect...
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) EE (Completed) LV (Completed) RO (Completed) LT (Completed) GR (Completed) IT (Completed) Outside EU/EEA
    Trial results: View results
    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: 2015-003662-87 Sponsor Protocol Number: Pseud-0708-MLJ Start Date*: 2015-11-13
    Sponsor Name:Aarhus University Hospital, Department of Respiratory Medicine
    Full Title: Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life
    Medical condition: Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10051190 Pneumonia Pseudomonas aeruginosa LLT
    18.1 100000004855 10050700 Chronic respiratory disease NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-001997-18 Sponsor Protocol Number: ACHN-490-007 Start Date*: 2014-02-25
    Sponsor Name:Achaogen, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriace...
    Medical condition: Bloodstream infections (BSI) and nosocomial pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Prematurely Ended) IT (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2022-000291-19 Sponsor Protocol Number: COL-ECMO2022 Start Date*: 2022-06-21
    Sponsor Name:Fakultní nemocnice u sv. Anny v Brně
    Full Title: Pharmacokinetics of colistin in critically ill patients with extracorporeal membrane oxygenation
    Medical condition: Pharmacokinetics in critically ill
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2007-006137-13 Sponsor Protocol Number: COL/VAP Start Date*: 2008-02-21
    Sponsor Name:Hospitales Universitarios Virgen del Rocío, Servicio Andaluz de Salud.
    Full Title: Estudio aleatorizado, doble ciego, comparando colistina intravenosa con colistina intravenosa más colistina intravenosa más colistina nebulizada en pacientes con neumonía asociada a ventilación mec...
    Medical condition: Neumonía asociada a ventilación mecánica por Acinetobacrter baumannii multi-resistente.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10035701 Pneumonia gram-negative bacterial NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-005583-25 Sponsor Protocol Number: COLIMERO Start Date*: 2014-07-16
    Sponsor Name:Consorci Parc de Salut Mar de Barcelona
    Full Title: Multicenter, randomized, open label, controlled clinical trial that compares the efficacy of the combination of colistin and meropenem versus monotherapy for the treatment of bacteremia and pneumon...
    Medical condition: Bacteriemia and Pneumonia due to Pseudomonas aeruginosa
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-005045-34 Sponsor Protocol Number: PPCTP/001 Start Date*: 2008-12-15
    Sponsor Name:Profile Pharma Ltd
    Full Title: A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cyst...
    Medical condition: non-CF bronchiectasis (CF = cystic fibrosis)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2013-004987-80 Sponsor Protocol Number: 2013-Colistin Start Date*: 2014-08-28
    Sponsor Name:CUB - Hôpital Erasme
    Full Title: Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance.
    Medical condition: Colistin use in Cystic Fibrosis patients
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004295-35 Sponsor Protocol Number: LCI-OUT Start Date*: 2014-04-30
    Sponsor Name:Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)
    Full Title: Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study
    Medical condition: Chronic lung P. Aeruginosa Infection
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10061229 Lung infection PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2019-000910-12 Sponsor Protocol Number: HT011 Start Date*: 2020-07-01
    Sponsor Name:Helperby Therapeutics Ireland Limited
    Full Title: A Double-blinded, Parallel-group, Randomized, Active-controlled Phase 2 Clinical Trial to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intravenous HY-001 Versus Standard Colis...
    Medical condition: complicated urinary tract infection (cUTI).
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Ongoing)
    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 (Ongoing) GR (Completed) HR (Completed) IT (Ongoing) RO (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-003933-27 Sponsor Protocol Number: POL7080-011 Start Date*: 2018-01-29
    Sponsor Name:Polyphor Ltd.
    Full Title: A multicenter, open-label, randomized, active-controlled, parallel group, pivotal study to investigate the efficacy, safety and tolerability, and pharmacokinetics of murepavadin combined with one a...
    Medical condition: Ventilator-associated bacterial pneumonia (VABP)
    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: HU (Prematurely Ended) EE (Prematurely Ended) ES (Prematurely Ended) FR (Prematurely Ended) HR (Ongoing) GR (Prematurely Ended) RO (Prematurely Ended)
    Trial results: (No results available)
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