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Clinical trials for Antibacterial activity

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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    18 result(s) found for: Antibacterial activity. Displaying page 1 of 1.
    EudraCT Number: 2016-004328-43 Sponsor Protocol Number: MK-7655A-020 Start Date*: 2017-09-19
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1b, Open-label, Single-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of MK-7655A in Pediatric Subjects From Birth to Less Than 18 Years of Age With Confirmed or Susp...
    Medical condition: Treatment of bacterial infections in pediatric populations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10071097 Beta-lactam antibiotic resistance LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NO (Completed) PL (Completed) Outside EU/EEA GB (Completed) BG (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-002192-40 Sponsor Protocol Number: periodld001 Start Date*: 2006-07-13
    Sponsor Name:Zsolt Lohinai DMD PhD
    Full Title: New treatment of periodontitis by inhibition of lysine decarboxilase enzyme
    Medical condition: healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004820-41 Sponsor Protocol Number: MK-7625A-035 Start Date*: 2017-08-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Plus Metronidazole Versus Meropen...
    Medical condition: Complicated intra-abdominal infection (cIAI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10056570 Intra-abdominal infection LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) ES (Completed) HU (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-011212-37 Sponsor Protocol Number: RD.03.SPR.29084 Start Date*: 2010-01-06
    Sponsor Name:Galderma research & Development
    Full Title: Anti P. acnes activity of Epiduo® Gel compared to Benzoyl Peroxide 2.5% Gel in the treatment of subjects with acne vulgaris
    Medical condition: Acne vulgaris with a high level of P. Acnes on the face (obeserved under wood's lamp)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10000519 Acne vulgaris LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PL (Completed)
    Trial results: View results
    EudraCT Number: 2020-001198-55 Sponsor Protocol Number: KronLungesyg_COVID_19_protokol_2 Start Date*: 2020-04-03
    Sponsor Name:Chronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)
    Full Title: Proactive Prophylaxis with Azithromycin and Hydroxychloroquine Patients Hospitalized with COVID
    Medical condition: This trial will investigate infection with coronavirus (COVID-19) in patients who are admitted to hospital
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    20.0 10022891 - Investigations 10070255 Coronavirus test positive PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-002780-42 Sponsor Protocol Number: TR701-111 Start Date*: 2015-06-29
    Sponsor Name:Trius Therapeutics [...]
    1. Trius Therapeutics
    2. Cubist Pharmaceuticals, Inc
    Full Title: A Phase 1, Open-Label, Multi-Center, Two-Part, Single-Dose, Parallel Design, Safety, Tolerance, and Pharmacokinetic Study of Orally and Intravenously Administered TR-701 FA in 12 to 17 Year Old Ad...
    Medical condition: Acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    18.0 10022891 - Investigations 10040879 Skin investigations HLGT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-011466-29 Sponsor Protocol Number: CXA 101-03 Start Date*: 2009-06-18
    Sponsor Name:Calixa Therapeutics Inc
    Full Title: A Multicenter, Double-blind, Randomized, Phase 2 Study to Compare the Safety and Efficacy of Intravenous CXA 101 and Intravenous Ceftazidime in Complicated Urinary Tract Infection, Including Pyelon...
    Medical condition: Complicated Urinary tract Infection including Pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037596 Pyelonephritis LLT
    9.1 10046571 Urinary tract infection LLT
    9.1 10054088 Urinary tract infection bacterial LLT
    9.1 10062279 Urinary tract infection pseudomonal LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) CZ (Prematurely Ended) BE (Completed)
    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: 2018-001451-13 Sponsor Protocol Number: VNRX-5133-201 Start Date*: 2019-07-02
    Sponsor Name:Venatorx Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Active-controlled Noninferiority Study Evaluating the Efficacy, Safety, and Tolerability of Cefepime/VNRX-5133 in Adults with Complicated Urinary Tract Infecti...
    Medical condition: Complicated Urinary Tract Infections, Including Acute Pyelonephritis
    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: LV (Completed) CZ (Completed) HU (Completed) BG (Completed) HR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-000953-38 Sponsor Protocol Number: MK-1986-014 Start Date*: 2018-02-07
    Sponsor Name:Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Single-and Multiple-Dose Safety and Pharmacokinetic Study of Oral and IV Tedizolid Phosphate (MK-1986) in Inpatients Under 2 Years Old
    Medical condition: Treatment or prophylaxis against Gram-positive infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: BG (Completed) GB (GB - no longer in EU/EEA) NO (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002888-18 Sponsor Protocol Number: CHAVANET-PHRC-2016 Start Date*: 2018-01-16
    Sponsor Name:CHU Dijon Bourgogne
    Full Title: Adjunction of daptomycin for the treatment of pneumococcal meningitis AddaMAP study
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10027253 Meningitis pneumococcal PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-001472-22 Sponsor Protocol Number: IMUNOR-201501 Start Date*: 2017-03-14
    Sponsor Name:ImunomedicA, a.s.
    Full Title: A Prospective, Randomized, Double-Blind, Placebo-controlled, Multicenter, Phase III Study Assessing Efficacy and Safety of the IMUNOR® Therapy Versus Placebo in Patients with Recurrent Vulvovaginit...
    Medical condition: Recurrent vulvovaginitis episodes
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10047794 Vulvovaginitis PT
    Population Age: Adults Gender: Female
    Trial protocol: SK (Completed) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000354-25 Sponsor Protocol Number: 2.1 Start Date*: 2021-11-11
    Sponsor Name:FINBA
    Full Title: A multicenter randomized trial of fosfomycin versus ciprofloxacin for febrile neutropenia in hematologic patients: efficacy and microbiologic safety.
    Medical condition: Post-chemotherapy neutropenia with high risk of developing infection in patients with acute leukemia undergoing induction, autologous or allogeneic hematopoietic stem cell transplantation.
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000835 Acute leukemia LLT
    20.0 100000004851 10076734 Chemotherapy induced neutropenia LLT
    22.0 100000004865 10067862 Allogeneic stem cell transplantation LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004153-32 Sponsor Protocol Number: MK-7625A-034 Start Date*: 2017-07-25
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Sub...
    Medical condition: Treatment of complicated urinary tract infection (cUTI), including pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10037606 Pyelonephritis, unspecified LLT
    20.0 100000004862 10046576 Urinary tract infection, site not specified LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed) GR (Completed) Outside EU/EEA RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-015953-18 Sponsor Protocol Number: DORIPED3002 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infec...
    Medical condition: Complicated Urinary Tract Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10046571 Urinary tract infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) CZ (Completed) PL (Temporarily Halted) LV (Prematurely Ended) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001296-32 Sponsor Protocol Number: FC/HULP-2014_01 Start Date*: 2014-07-07
    Sponsor Name:Fundación para la Investigación Biomédica del Hospital Universitario de La Paz
    Full Title: Pharmacokinetic and pharmacodynamic optimization of amikacin treatment in patients with terminal renal failure under conventional hemodialysis: randomized clinical trial of two model of administration
    Medical condition: Terminal renal failure under hemodialysis
    Disease: Version SOC Term Classification Code Term Level
    17.0 10038359 - Renal and urinary disorders 10038444 Renal failure chronic PT
    17.0 10038359 - Renal and urinary disorders 10014647 End stage renal failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2012-002491-14 Sponsor Protocol Number: Sepsis_IFNg Start Date*: 2012-11-08
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: The effects of interferon-gamma on sepsis-induced immunoparalysis, a randomised double-blind placebo-controlled pilot (Phase IIIb) study
    Medical condition: Sepsis-induced immunoparalysis (SIRS, Sepsis, Septic shock)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10018065 - General disorders and administration site conditions 10062357 SIRS LLT
    14.1 10018065 - General disorders and administration site conditions 10061218 Inflammation PT
    14.1 10021881 - Infections and infestations 10040047 Sepsis PT
    14.1 10021428 - Immune system disorders 10061598 Immunodeficiency PT
    14.1 10021881 - Infections and infestations 10040070 Septic shock PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    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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