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Clinical trials for Polymyxin

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   44334   clinical trials with a EudraCT protocol, of which   7366   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    9 result(s) found for: Polymyxin. Displaying page 1 of 1.
    EudraCT Number: 2022-002856-37 Sponsor Protocol Number: BV100-006 Start Date*: 2023-01-30
    Sponsor Name:BioVersys SAS
    Full Title: A multicenter, open-label, randomized, active-controlled, Phase 2 study to evaluate the pharmacokinetics, efficacy, and safety of intravenous BV100 combined with Polymyxin B versus best available t...
    Medical condition: ventilator-associated bacterial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004862 10081414 Ventilator associated bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-001179-36 Sponsor Protocol Number: C-04-72 Start Date*: 2005-08-23
    Sponsor Name:Alcon Pharma GmbH
    Full Title: Efficacy and safety of Dexa-Polyspectran® drops, preserved with benzalkonium chloride, vs. Dexa-Polyspectran® drops without dexamethasone phosphate, preserved with benzalkonium chloride, in patient...
    Medical condition: acute bacterial otitis externa
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2005-001180-65 Sponsor Protocol Number: C-04-73 Start Date*: 2005-08-22
    Sponsor Name:Alcon Pharma GmbH
    Full Title: Efficacy and safety of Polyspectran® drops, preserved with benzalkonium chloride vs. glycerol ear drops in patients with acute bacterial otitis externa – A double-blind, multicenter, prospective, ...
    Medical condition: acute bacterial otitis externa
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000546-30 Sponsor Protocol Number: Rempex-506 Start Date*: 2015-04-21
    Sponsor Name:Rempex Pharmaceuticals, Inc.
    Full Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTERO...
    Medical condition: serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), complicated intra-abdominal infections (cIAI), hospital acquired bacterial pneumonia (HABP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10003999 Bacteremia LLT
    18.0 100000004862 10001032 Acute pyelonephritis LLT
    18.0 100000004862 10056570 Intra-abdominal infection LLT
    18.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    18.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) ES (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001759-22 Sponsor Protocol Number: PGX401-11 Start Date*: 2015-07-24
    Sponsor Name:Laboratoire Innotech International
    Full Title: Assessment of the efficacy of POLYGYNAX® in the empirical treatment of infectious vaginitis International, multicentre, randomised, double-blind, parallel group study, comparative versus miconazole
    Medical condition: Patients presenting with abnormal vaginal discharge associated with other vaginal symptoms (i.e. vaginal burning and/or vaginal irritation and/or vaginal pain) clinically evoking infectious vaginit...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10046950 Vaginitis LLT
    18.0 10021881 - Infections and infestations 10046914 Vaginal infection PT
    18.0 10021881 - Infections and infestations 10001107 Acute vaginitis LLT
    18.0 10021881 - Infections and infestations 10029562 Non-specific vaginitis LLT
    18.0 10021881 - Infections and infestations 10062167 Vaginitis bacterial PT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2018-002526-23 Sponsor Protocol Number: CS2514-2017-0004 Start Date*: 2019-05-07
    Sponsor Name:Entasis Therapeutics
    Full Title: A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter baumannii-calcoacetic...
    Medical condition: Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10003999 Bacteremia LLT
    20.0 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    20.1 10021881 - Infections and infestations 10037597 Pyelonephritis acute PT
    20.0 10021881 - Infections and infestations 10076918 Hospital acquired pneumonia LLT
    20.1 10021881 - Infections and infestations 10065153 Ventilator associated pneumonia LLT
    20.0 10021881 - Infections and infestations 10078408 Surgical site infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004544-38 Sponsor Protocol Number: C3601009 Start Date*: 2020-07-03
    Sponsor Name:Pfizer Inc.
    Full Title: A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, COMPARATIVE STUDY TO ASSESS THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) AND BEST AVAILABLE THERAPY FOR THE TREATMENT OF SERIOUS INF...
    Medical condition: SERIOUS INFECTIONS DUE TO MULTI-DRUG RESISTANT GRAM- NEGATIVE BACTERIA PRODUCING METALLO-Β-LACTAMASE (MBL)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10021804 Infection bacterial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Prematurely Ended) RO (Ongoing)
    Trial results: View results
    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 (Completed)
    Trial results: View results
    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)
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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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