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Clinical trials for Dalbavancin

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 ).  
     
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    13 result(s) found for: Dalbavancin. Displaying page 1 of 1.
    EudraCT Number: 2020-003169-20 Sponsor Protocol Number: 20-AOI-03 Start Date*: 2020-10-20
    Sponsor Name:CHU de Nice
    Full Title: Efficacy of dalbavancin during osteo-articular infections associated with hip and knee prostheses
    Medical condition: Osteo-articular infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10075981 Staphylococcus aureus infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000419-15 Sponsor Protocol Number: DUR001-303 Start Date*: 2014-07-28
    Sponsor Name:Durata Therapeutics International B.V.
    Full Title: A Phase 3b, Double-Blind, Multicenter, Randomized Study to Compare the Efficacy and Safety of Single Dose Dalbavancin to a Two Dose Regimen of Dalbavancin for the Treatment of Acute Bacterial Skin ...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) EE (Completed) HU (Completed) BG (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004130-25 Sponsor Protocol Number: DUR001-304 Start Date*: 2016-03-07
    Sponsor Name:Durata Therapeutic International B.V.
    Full Title: A phase 3, Multicenter, Double-Blind, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Hematogenous Osteom...
    Medical condition: Acute Hematogenous Osteomyelitis of the Long Bones Known or Suspected to be due to Gram-Positive Organisms
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-024042-30 Sponsor Protocol Number: DUR001-301 Start Date*: 2012-05-04
    Sponsor Name:Durata Therapeutics, Inc
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO COMPARE THE EFFICACY AND SAFETY OF DALBAVANCIN TO A COMPARATOR REGIMEN (VANCOMYCIN AND LINEZOLID) FOR THE TREATMENT OF ACUTE BACTERIAL SKI...
    Medical condition: acute bacterial skin and skin structure infections (abSSSI)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10004035 Bacterial infection due to staphylococcus aureus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002683-32 Sponsor Protocol Number: DUR001-305 Start Date*: 2015-03-30
    Sponsor Name:Durata Therapeutics International B.V.
    Full Title: A Phase 3, double-blinded, randomized, comparator trial of the safety and efficacy of a single dose of dalbavancin to twice daily linezolid for the treatment of community acquired bacterial pneumonia
    Medical condition: Community acquired bacterial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10010120 Community acquired pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-002130-40 Sponsor Protocol Number: DUR001-302 Start Date*: 2011-11-23
    Sponsor Name:Durata Therapeutics, Inc
    Full Title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO COMPARE THE EFFICACY AND SAFETY OF DALBAVANCIN TO A COMPARATOR REGIMEN (VANCOMYCIN AND LINEZOLID) FOR THE TREATMENT OF ACUTE BACTERIAL SK...
    Medical condition: acute bacterial skin and skin structure infections (abSSSI)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10004035 Bacterial infection due to staphylococcus aureus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) LT (Completed) HU (Completed) LV (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2022-000415-32 Sponsor Protocol Number: DAL-PK-02 Start Date*: 2022-06-07
    Sponsor Name:Allergan
    Full Title: Pharmacokinetics of a Single-Dose of Dalbavancin in Preterm Neonates to Infants Ages 3 Months With Suspected or Confirmed Bacterial Infection
    Medical condition: Bacterial Infection in hospitalized children
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10004044 Bacterial infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-003227-11 Sponsor Protocol Number: DUR001-106 Start Date*: 2014-11-28
    Sponsor Name:Durata Therapeutics International B.V.
    Full Title: PHASE 1, OPEN LABEL, SINGLE DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF DALBAVANCIN IN HOSPITALIZED CHILDREN AGED 3 MONTHS TO 11 YEARS RECEIVING STANDARD INTRAVENOUS ...
    Medical condition: Bacterial Infection in hospitalized children
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10004044 Bacterial infection NOS LLT
    17.0 100000004862 10004043 Bacterial infection in conditions classified elsewhere and of unspecified site LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2021-004038-12 Sponsor Protocol Number: 19-01 Start Date*: 2021-12-10
    Sponsor Name:CENTRE HOSPITALIER ANNECY GENEVOIS
    Full Title: Randomized open-label controlled trial evaluating a single-dose intravenous Dalbavancin versus standard antibiotic therapy during catheter-related bloodstream infections due to Staphylococcus aureus
    Medical condition: Staphylococcus aureus catheter bloodstream infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-005281-30 Sponsor Protocol Number: DUR001-306 Start Date*: 2016-11-03
    Sponsor Name:Allergan Ltd.
    Full Title: A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin versus Active Comparator in Pediatric Subjects with Acute Bacterial Skin and Sk...
    Medical condition: Acute bacterial skin and skin structure infection. For Cohort 5 (from birth to less than 3 months) also patients with sepsis are allowed.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10066412 Staphylococcus aureus skin infection LLT
    20.0 10021881 - Infections and infestations 10037633 Pyoderma (skin infection) LLT
    20.1 10021881 - Infections and infestations 10040873 Skin infection aggravated LLT
    20.0 10021881 - Infections and infestations 10040872 Skin infection PT
    20.0 10021881 - Infections and infestations 10040875 Skin infection pyogenic LLT
    20.0 10021881 - Infections and infestations 10040874 Skin infection NOS LLT
    20.1 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    20.0 10021881 - Infections and infestations 10040047 Sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Prematurely Ended) LT (Prematurely Ended) ES (Prematurely Ended) BG (Completed) GR (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2017-000934-77 Sponsor Protocol Number: 4.0 Start Date*: 2018-05-11
    Sponsor Name:Medical University of Vienna
    Full Title: Target attainment of Cefazolin Continuous Infusion for Antibiotic Prophylaxis in patients undergoing CABG surgery
    Medical condition: Patients referred for CABG to the Department of Cardiac Surgery with planned isolated left mammary artery and vein/radial artery grafts preparation will be asked to participate in this trial.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003612-39 Sponsor Protocol Number: INF-BACT-2017 Start Date*: 2018-04-25
    Sponsor Name:Fundació Parc Taulí
    Full Title: Randomized clinical trial on the need for antibiotic to treat low-risk catheter bacteremia due to coagulase-negative staphylococci.
    Medical condition: Catheter bacteremia caused by coagulase-negative staphylococci.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10054637 Staphylococcal bacteremia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    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
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