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Clinical trials for Gram negative bacteria

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   44335   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 ).  
     
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    71 result(s) found for: Gram negative bacteria. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2014-003485-24 Sponsor Protocol Number: CXA-PEDS-13-08 Start Date*: 2014-09-25
    Sponsor Name:Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic ...
    Medical condition: This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    20.0 100000004865 10049086 Antibacterial prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2016-000656-99 Sponsor Protocol Number: REMPEX-507 Start Date*: 2023-09-28
    Sponsor Name:Rempex Pharmaceuticals-Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years o...
    Medical condition: Suspected or confirmed negative bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-004154-22 Sponsor Protocol Number: TR701-132 Start Date*: 2014-04-17
    Sponsor Name:Trius Therapeutics, a Wholly Owned Subsidiary of Cubist Pharmaceuticals, Inc.
    Full Title: A Phase 3 Randomized Double-blind Study Comparing TR 701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
    Medical condition: Ventilated Gram-positive nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) AT (Completed) DE (Completed) BE (Completed) ES (Completed) GR (Completed) SK (Completed) CZ (Completed) EE (Completed) GB (Completed) HR (Completed) PT (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002343-99 Sponsor Protocol Number: 1.0 Start Date*: 2012-01-03
    Sponsor Name:Heart of England NHS Foundation Trust
    Full Title: An Open-label Study into the Efficacy and Dosing of Probiotic Escherichia coli Nissle 1917 for Prevention of Gram-negative Gastric Colonisation in Ventilated Intensive Care Patients.
    Medical condition: Gastric colonisation by pathogenic gram negative bacteria in ventilated adult ICU patients and it's prevention by the probiotic E.coli Nissle 1917
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-003282-17 Sponsor Protocol Number: 190801 Start Date*: 2020-02-11
    Sponsor Name:Thomas Benfield
    Full Title: Short course antibiotic treatment of Gram-negative bacteremia: A multicenter, randomized, non-blinded, non-inferiority interventional study
    Medical condition: Gram-negative bacteremia
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10054228 Gram-negative bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2012-001496-36 Sponsor Protocol Number: AMPISUL/AMOXICLAV-HD_V1.4 Start Date*: 2013-07-19
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme
    Full Title: Multiple-dose pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis in longterm haemodialysis patients
    Medical condition: Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    14.1 10021881 - Infections and infestations 10035649 Pneumococcal secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10004038 Bacterial infection due to streptococcus, group C LLT
    14.1 10021881 - Infections and infestations 10004039 Bacterial infection due to streptococcus, group D LLT
    16.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    14.1 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    14.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    14.1 10021881 - Infections and infestations 10004042 Bacterial infection due to unspecified streptococcus LLT
    14.1 10021881 - Infections and infestations 10004037 Bacterial infection due to streptococcus, group B LLT
    14.1 10021881 - Infections and infestations 10054278 Bacterial infection due to streptococcus, group F LLT
    14.1 10021881 - Infections and infestations 10004041 Bacterial infection due to unspecified staphylococcus LLT
    14.1 10021881 - Infections and infestations 10004036 Bacterial infection due to streptococcus, group A LLT
    14.1 10021881 - Infections and infestations 10004044 Bacterial infection NOS LLT
    14.1 10021881 - Infections and infestations 10004035 Bacterial infection due to staphylococcus aureus LLT
    14.1 10021881 - Infections and infestations 10004040 Bacterial infection due to streptococcus, group G LLT
    14.1 10021881 - Infections and infestations 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-001048-73 Sponsor Protocol Number: BAY41-6551/13084 Start Date*: 2013-07-25
    Sponsor Name:Bayer AG
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati...
    Medical condition: Gram-negative pneumonia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10035701 Pneumonia gram-negative bacterial NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    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: 2008-000906-35 Sponsor Protocol Number: BAY41-6551/13085 Start Date*: 2008-11-28
    Sponsor Name:Bayer Schering Pharma AG
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of BAY 41-6551 as Adjunctive Therapy in Intubated and Mechanically-Ventilated Pati...
    Medical condition: Gram-negaive pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) NL (Completed) BE (Completed) ES (Completed) FR (Completed) LV (Prematurely Ended) GR (Completed) PT (Completed) IT (Prematurely Ended) PL (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: 2018-003865-32 Sponsor Protocol Number: AZLI-2018-AR Start Date*: 2019-01-22
    Sponsor Name:Alejandro Rodriguez Oviedo ‐ Critical Care Department – Hospital Universitario de Tarragona Joan XXIII
    Full Title: Efficacy, safety and pharmacokinetics profile of nebulized Aztreonam Lysine (AZLI) for prevention of Gram negative pneumonia in heavily colonized mechanically ventilated patients: AZLIS
    Medical condition: Gram negative pneumonia in heavily colonized mechanically ventilated patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10035725 Pneumonia NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2013-002855-13 Sponsor Protocol Number: CAP-01-102 Start Date*: 2014-02-14
    Sponsor Name:Cardeas Pharma
    Full Title: A Randomized Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study of Aerosolized Amikacin and Fosfomycin Delivered via the Investigational eFlow® Inline System in Mechanically Ventilated...
    Medical condition: Gram-negative Bacterial Pneumonia in Mechanically Ventilated Patients
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) GR (Completed) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003708-22 Sponsor Protocol Number: E2015-PK-USI-BMR-COLISTIN Start Date*: 2015-10-23
    Sponsor Name:Hospital Erasme
    Full Title: Colistin use in critically ill patients: pharmacokinetic population and pharmacodynamic studies, tolerance profil and risk of selection of resistance
    Medical condition: Patients in intensive care unit suffering of infection by multi-drug resistance bacteria treated by colistin
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10040054 Sepsis, bacteraemia, viraemia and fungaemia NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-023959-28 Sponsor Protocol Number: GS-US-219-0104 Start Date*: 2011-07-04
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solutio...
    Medical condition: Non-CF bronchiectasis and gram-negative endobronchial infection
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006445 Bronchiectasis PT
    14.1 10021881 - Infections and infestations 10070295 Infective exacerbation of bronchiectasis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) NL (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004819-31 Sponsor Protocol Number: 1787/12 Start Date*: 2013-07-08
    Sponsor Name:RADBOUD UNIVERSITY NIJMEGEN MEDICAL CENTER
    Full Title: Multicenter open-label RCT to compare colistin alone vs. colistin plus meropenem
    Medical condition: INFECTIONS DUE TO CARBAPENEM RESISTENT GRAM NEGATIVE BACTERIA
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10004047 Bacterial infections NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing) GR (Completed)
    Trial results: (No results available)
    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: 2015-004595-29 Sponsor Protocol Number: TR701-120/MK-1986-013 Start Date*: 2016-01-08
    Sponsor Name:Cubist Pharmaceuticals, LLC
    Full Title: A Phase 1, Single-Administration Pharmacokinetic and Safety Study of Oral and IV Tedizolid Phosphate in Hospitalized Subjects 2 to <12 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053021 Gram-positive bacterial infection LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA GB (Completed)
    Trial results: View results
    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: 2016-003020-23 Sponsor Protocol Number: 1615R2132 Start Date*: 2017-11-23
    Sponsor Name:Shionogi B.V.
    Full Title: A Multicenter, Randomized, Double-blind, Parallelgroup, Clinical Study of S-649266 Compared with Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacteria...
    Medical condition: Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.0 10021881 - Infections and infestations 10076918 Hospital acquired pneumonia LLT
    20.1 10021881 - Infections and infestations 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) LV (Completed) HU (Completed) ES (Completed) BE (Completed)
    Trial results: View results
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