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Clinical trials for Skin and subcutaneous tissue infections and infestations

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    15 result(s) found for: Skin and subcutaneous tissue infections and infestations. Displaying page 1 of 1.
    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: 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: 2004-001662-41 Sponsor Protocol Number: BAP00154 Start Date*: 2004-09-16
    Sponsor Name:Basilea Pharmaceutica Ltd
    Full Title: A Phase III, Randomized, Double-Blind Study of Ceftobiprole versus Vancomycin in the Treatment of Complicated Skin and Skin Structure Infections
    Medical condition: Complicated skin and skin structure infections
    Disease: Version SOC Term Classification Code Term Level
    LLT 10024768 code
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) LV (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2004-000422-73 Sponsor Protocol Number: DAM/001/03 Start Date*: 2004-09-28
    Sponsor Name:FARMACEUTICI DAMOR
    Full Title: OPEN-LABEL, CONTROLLED, RANDOMISED, MULTICENTRE, PARALLEL GROUP CLINICAL TRIAL OF EFFICACY AND TOLERABILITY OF FITOSTIMOLINE ANTIBIOTICO SOAKED GAUZES AND CITRIZAN GEL ANTIBIOTIC IN THE TOPICAL TRE...
    Medical condition: TREATMENT OF CUTANEOUS SORES, ULCERS AND BURNS, COMPLICATED WITH BACTERIAL CONTAMINATION
    Disease: Version SOC Term Classification Code Term Level
    10040792 HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    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: 2018-001125-15 Sponsor Protocol Number: ATB-202 Start Date*: 2018-07-16
    Sponsor Name:Atox Bio
    Full Title: Phase III, randomized, double-blind, placebo controlled, parallel-group, study of AB103 as compared to placebo in patients with necrotizing soft tissue infections (NSTI)
    Medical condition: Necrosis of soft tissue infections (NSTI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10065769 Soft tissue necrosis PT
    20.0 10021881 - Infections and infestations 10017068 Fournier's gangrene LLT
    20.1 10021881 - Infections and infestations 10028885 Necrotising fasciitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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: 2009-014391-22 Sponsor Protocol Number: CCBC134A2404 Start Date*: Information not available in EudraCT
    Sponsor Name:Novartis Pharma AG
    Full Title: An open label, multi-center, randomized, comparative Phase IIIb study to compare efficacy and safety of intravenous (i.v.) daptomycin with that of Semi-synthetic Penicillins (SSPs) or vancomycin in...
    Medical condition: complicated skin and soft tissue infections.
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed) IT (Completed) ES (Completed) AT (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: 2016-002249-53 Sponsor Protocol Number: P150924 Start Date*: 2023-02-16
    Sponsor Name:Assistance Publique - Hôpitaux de Paris (AP-HP)
    Full Title: Comparing short to standard amoxicillin course for eRysipElas: a non-inferiority randomized controlled trial
    Medical condition: Adults diagnosed with lower limbs erysipelas/ cellulitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10037632 Pyoderma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-004018-15 Sponsor Protocol Number: V710-003 Start Date*: 2008-01-17
    Sponsor Name:Merck Sharp & Dohme (Sweden) AB
    Full Title: A Randomized, Multicenter, Double-Blind, Group-Sequential Study to Evaluate the Efficacy, Immunogenicity, and Safety of a Single Dose of Merck 0657nI Staphylococcus aureus Vaccine (V710) in Adult P...
    Medical condition: Staphylococcus aureus bacteremia Staphylococcus aureus mediastinitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10058887 Staphylococcus aureus bacteremia LLT
    14.0 10021881 - Infections and infestations 10066413 Staphylococcus aureus mediastinitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) DE (Prematurely Ended) BE (Completed) ES (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) IT (Prematurely Ended) AT (Completed) FR (Prematurely Ended) IE (Prematurely Ended) DK (Prematurely Ended) HU (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000784-97 Sponsor Protocol Number: SB-275833/032 Start Date*: 2004-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: A Randomized, Double-blind, Double-Dummy, Multicenter, Non-inferiority Phase III Study to Assess the Safety and Efficacy of Topical 1% SB-275833 Ointment, Applied Twice Daily, versus Oral Cephalexi...
    Medical condition: Secondarily-Infected Dermatoses
    Disease: Version SOC Term Classification Code Term Level
    7.0 10012470 PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-003740-89 Sponsor Protocol Number: MR-Som-01-20 Start Date*: 2020-11-26
    Sponsor Name:SOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
    Full Title: A Phase IV, interventional, monocentric, not controlled study for the evaluation of new clinical and instrumental parameters on the efficacy of SOMATOLINE in the treatment of local adiposity and ce...
    Medical condition: local adiposity and cellulite
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10007882 Cellulitis PT
    Population Age: Adults Gender: Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-003248-36 Sponsor Protocol Number: 61383082 Start Date*: 2011-09-30
    Sponsor Name:Central Military Hospital
    Full Title: The clinical significance of epigenetic factors research to refine the diagnosis, estimate prognosis and risk of recurrence after curative pancreatic cancer resection.
    Medical condition: The aim of the study to estimate frequence of epigenetics changes in pancreatic cancer and to assess the signidicance of apllication of the intravenous contrast agent during endosonography to bette...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10018065 - General disorders and administration site conditions 10016335 Feeling hot and cold LLT
    14.0 10040785 - Skin and subcutaneous tissue disorders 10037872 Rash NOS LLT
    14.0 10037175 - Psychiatric disorders 10032168 Other insomnia LLT
    14.0 10007541 - Cardiac disorders 10008481 Chest pain - cardiac LLT
    14.0 10017947 - Gastrointestinal disorders 10064907 Functional abdominal pain LLT
    14.0 10029205 - Nervous system disorders 10048324 Dizziness aggravated LLT
    14.0 10029205 - Nervous system disorders 10033777 Paraesthesia distal LLT
    14.0 10022891 - Investigations 10050786 Fasting blood glucose increased LLT
    14.0 10018065 - General disorders and administration site conditions 10022096 Injection site reaction NOS LLT
    14.0 10021881 - Infections and infestations 10034838 Pharyngitis NOS LLT
    14.0 10018065 - General disorders and administration site conditions 10016259 Fatigueability LLT
    14.0 10021428 - Immune system disorders 10020762 Hypersensitivity type I LLT
    14.0 10028395 - Musculoskeletal and connective tissue disorders 10048412 Back pain aggravated LLT
    14.0 10021428 - Immune system disorders 10020756 Hypersensitivity reaction LLT
    14.0 10017947 - Gastrointestinal disorders 10028822 Nauseated LLT
    14.0 10047065 - Vascular disorders 10048347 Flushing aggravated LLT
    14.0 10029205 - Nervous system disorders 10024857 Loss of consiousness LLT
    14.0 10029205 - Nervous system disorders 10019218 Headache NOS LLT
    14.0 10040785 - Skin and subcutaneous tissue disorders 10037096 Pruritus NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-006319-69 Sponsor Protocol Number: 1.0 Start Date*: 2012-10-25
    Sponsor Name:Pedro Villarejo Campos(Hospital Universitario Ciudad Real)
    Full Title: Closed abdomen hyperthermic intraperitoneal chemotherapy with paclitaxel for advanced epithelial ovarian cancer
    Medical condition: ovarian cancer (II,III,IV FIGO staging and tumoral recurrence)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10028584 Myelosuppression LLT
    14.1 10007541 - Cardiac disorders 10006093 Bradycardia PT
    14.1 10017947 - Gastrointestinal disorders 10028813 Nausea PT
    14.1 10017947 - Gastrointestinal disorders 10012727 Diarrhea LLT
    14.1 10017947 - Gastrointestinal disorders 10047700 Vomiting PT
    14.1 10018065 - General disorders and administration site conditions 10028127 Mucositis LLT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10003239 Arthralgia PT
    14.1 10040785 - Skin and subcutaneous tissue disorders 10001760 Alopecia PT
    14.1 10021881 - Infections and infestations 10046544 Urinary infection LLT
    14.1 10047065 - Vascular disorders 10021097 Hypotension PT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028411 Myalgia PT
    14.1 10021881 - Infections and infestations 10038700 Respiratory infection LLT
    14.1 10029205 - Nervous system disorders 10034610 Peripheral neuropathy NOS LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (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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