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Clinical trials for Bacterial Infections AND Gram-positive Bacterial Infection AND daptomycin

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   43846   clinical trials with a EudraCT protocol, of which   7282   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: Bacterial Infections AND Gram-positive Bacterial Infection AND daptomycin. Displaying page 1 of 1.
    EudraCT Number: 2015-000125-36 Sponsor Protocol Number: Dapto Start Date*: 2016-08-02
    Sponsor Name:University Hospital Tübingen
    Full Title: Daptomycin concentration in drainage fluid and blood samples of ICU patients
    Medical condition: Intensive Care Patients after Surgery treated with Daptomycin and wound draingae
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-002779-64 Sponsor Protocol Number: DAP-PEDS-09-01 Start Date*: 2015-06-29
    Sponsor Name:Cubist Pharmaceuticals, Inc.
    Full Title: An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic T...
    Medical condition: Gram Positive Bacterial Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-001576-15 Sponsor Protocol Number: MK-3009-029 Start Date*: 2020-05-28
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase II Open-Label, Single-arm Clinical Trial to Study the Safety, Efficacy and Pharmacokinetics of MK-3009 (Daptomycin) in Japanese Pediatric Participants Aged 1 to 17 Years with Complicated Sk...
    Medical condition: Complicated Skin and Soft Tissue Infections or Bacteremia caused by Gram-positive cocci
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-002778-19 Sponsor Protocol Number: DAP-PEDS-07-03 Start Date*: 2015-06-29
    Sponsor Name:Cubist Pharmaceuticals, Inc.
    Full Title: An Evaluation of the Safety, Efficacy and Pharmacokinetics of Daptomycin in Pediatric Subjects Aged One to Seventeen Years With Complicated Skin and Skin Structure Infections Caused by Gram-Positiv...
    Medical condition: Complicated skin and skin structure infections (cSSSI) caused by Gram-positive pathogens
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-000864-28 Sponsor Protocol Number: DAP-PEDOST-11-03 Start Date*: 2014-01-02
    Sponsor Name:Cubist Pharmaceuticals, LLC
    Full Title: A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogeno...
    Medical condition: Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10009081 Chronic osteomyelitis LLT
    19.1 100000004862 10046076 Unspecified osteomyelitis LLT
    19.1 100000004862 10009091 Chronic osteomyelitis, site unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) IT (Completed) ES (Completed) GR (Completed) LV (Completed) GB (Completed) EE (Completed) BG (Completed) FR (Completed) SI (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003447-29 Sponsor Protocol Number: DAP-PEDBAC-11-02 Start Date*: 2013-06-11
    Sponsor Name:Cubist Pharmaceuticals, Inc.
    Full Title: A COMPARATIVE EVALUATION OF THE SAFETY AND EFFICACY OF DAPTOMYCIN VERSUS STANDARD OF CARE IN PEDIATRIC SUBJECTS TWO - SEVENTEEN YEARS OF AGE WITH BACTEREMIA CAUSED BY STAPHYLOCOCCUS AUREUS.
    Medical condition: Bacteremia caused by Staphylococcus Aureus.
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10054637 Staphylococcal bacteremia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) HU (Completed) GR (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003741-17 Sponsor Protocol Number: PMX63-203 Start Date*: 2012-01-17
    Sponsor Name:PolyMedix Inc.
    Full Title: Randomized, Dose Ranging, Active Controlled Efficacy and Safety Evaluation of PMX-30063 As Initial Treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections (ABSSSI) Caused by Staphylococcus aureus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10040786 Skin structures and soft tissue infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000203-89 Sponsor Protocol Number: NeoVanc Start Date*: 2016-07-18
    Sponsor Name:Fondazione PENTA Onlus
    Full Title: Multi-centre, randomised, open label, phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and inf...
    Medical condition: Neonatal late onset sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended) EE (Ongoing) ES (Prematurely Ended) GR (Prematurely Ended)
    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 (Ongoing)
    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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