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Clinical trials for abSSSI

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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    20 result(s) found for: abSSSI. Displaying page 1 of 1.
    EudraCT Number: 2022-001297-63 Sponsor Protocol Number: MLORI201 Start Date*: 2023-04-13
    Sponsor Name:Melinta Therapeutics, LLC
    Full Title: A Multicenter, Open-Label, Evaluator-Blinded, Randomized Study to Evaluate the Safety and Tolerability of Single-Dose IV Oritavancin Versus Standard of Care for the Treatment of Pediatric Subjects...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Trial now transitioned) LT (Trial now transitioned) LV (Trial now transitioned) PL (Trial now transitioned) ES (Ongoing) PT (Trial now transitioned) RO (Trial now transitioned) GR (Trial now transitioned)
    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: 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: 2015-002669-45 Sponsor Protocol Number: ICL-23-ABSSSI1 Start Date*: 2016-02-18
    Sponsor Name:Motif BioSciences Inc.
    Full Title: A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infe...
    Medical condition: Acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens.
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) DE (Completed) BG (Completed) PL (Completed)
    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: 2015-002687-16 Sponsor Protocol Number: ICL-24-ABSSSI2 Start Date*: 2016-05-05
    Sponsor Name:Motif BioSciences Inc.
    Full Title: A Phase 3, randomized, double-blind, multicenter study to evaluate the safety and efficacy of intravenous iclaprim versus vancomycin in the treatment of acute bacterial skin and skin structure infe...
    Medical condition: Acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens.
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) BE (Completed) HU (Completed) PT (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2016-003884-20 Sponsor Protocol Number: MK-1986-018 Start Date*: 2017-06-05
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase III Randomized, Active-comparator-Controlled Clinical Trial to Study the Safety and Efficacy of MK-1986 (Tedizolid Phosphate) and Comparator, in Subjects 3 Months to <12 Years of Age with A...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA DE (Completed) PL (Completed) BG (Completed) LT (Completed) LV (Completed)
    Trial results: View results
    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: 2010-022168-11 Sponsor Protocol Number: TR-701-112 Start Date*: 2011-03-08
    Sponsor Name:Trius Therapeutics, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of 6-Day Oral TR-701 Free Acid and 10-Day Oral Linezolid for the Treatment of Acute Bacterial Skin and Skin...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed) LV (Completed) HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2017-001605-32 Sponsor Protocol Number: BPR-CS-008 Start Date*: 2017-10-06
    Sponsor Name:Basilea Pharmaceutica International Ltd
    Full Title: A randomized, double-blind, multicenter study to establish the safety and efficacy of ceftobiprole medocaril compared with vancomycin plus aztreonam in the treatment of acute bacterial skin and ski...
    Medical condition: Acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2011-002860-26 Sponsor Protocol Number: TR701-113 Start Date*: 2011-12-21
    Sponsor Name:Trius Therapeutics, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Multicenter Study Comparing the Efficacy and Safety of Intravenous to Oral 6-Day TR-701 Free Acid and Intravenous to Oral 10-Day Linezolid for the Treatment of...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-003812-22 Sponsor Protocol Number: P903-23 Start Date*: 2011-10-31
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Ceftaroline Versus Comparator in Pediatric Subjects With...
    Medical condition: Acute Bacterial Skin and Skin Structure Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA LT (Completed) LV (Completed) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003644-23 Sponsor Protocol Number: PTK0796-ABSI-1108 Start Date*: 2015-07-02
    Sponsor Name:Paratek Pharma LLC
    Full Title: A Phase 3 Randomized, Double-Blind, Multi-Center Study to Compare the Safety and Efficacy of Omadacycline IV/PO to Linezolid IV/PO for Treating Adult Subjects with Acute Bacterial Skin and Skin Str...
    Medical condition: Acute Bacterial Skin and Skin Structure Infection
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10040872 Skin infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) ES (Completed) PL (Completed) GR (Completed) HR (Completed)
    Trial results: View results
    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: 2010-021424-94 Sponsor Protocol Number: TMC-ORI-10-01 Start Date*: 2012-03-16
    Sponsor Name:The Medicines Company
    Full Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin for the Treatment of Patients with Acute Bacterial Skin and Skin...
    Medical condition: Treatment of Patients with acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10065240 Wound infection bacterial PT
    14.0 10021881 - Infections and infestations 10040872 Skin infection PT
    14.0 10021881 - Infections and infestations 10042343 Subcutaneous abscess PT
    14.0 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    14.0 10021881 - Infections and infestations 10007882 Cellulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) PL (Prematurely Ended) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021720-10 Sponsor Protocol Number: TMC-ORI-10-02 Start Date*: 2012-03-16
    Sponsor Name:The Medicines Company
    Full Title: A Multicenter, Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of Single-Dose IV Oritavancin versus IV Vancomycin for the Treatment of Patients with Acute Bacterial Skin and Skin...
    Medical condition: Treatment of Patients with acute bacterial skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10065240 Wound infection bacterial PT
    14.1 10021881 - Infections and infestations 10040872 Skin infection PT
    14.1 10021881 - Infections and infestations 10042343 Subcutaneous abscess PT
    14.1 10021881 - Infections and infestations 10066409 Staphylococcal skin infection PT
    14.1 10021881 - Infections and infestations 10007882 Cellulitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001528-69 Sponsor Protocol Number: EmergencyMedicineTrial001 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: PENICILLIN FOR THE EMERGENCY DEPARTMENT-DIRECTED OUTPATIENT TREATMENT OF CELLULITIS (PEDOCELL) STUDY: A NON-INFERIORITY ADAPTIVE RANDOMISED CONTROLLED TRIAL.
    Medical condition: Skin Infection
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    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: 2012-001767-71 Sponsor Protocol Number: RX-3341-302 Start Date*: 2013-06-20
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE BLIND, ACTIVE CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE BACTERIAL S...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LV (Completed) ES (Completed) BG (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2014-004983-39 Sponsor Protocol Number: RX-3341-303 Start Date*: 2015-01-26
    Sponsor Name:Melinta Therapeutics, Inc
    Full Title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF IV AND ORAL DELAFLOXACIN COMPARED WITH VANCOMYCIN + AZTREONAM IN PATIENTS WITH ACUTE...
    Medical condition: ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10052891 Skin bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) EE (Completed) LV (Completed) SK (Completed) BG (Completed)
    Trial results: View results
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