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Clinical trials for Gram-Positive Bacterial Infections

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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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    58 result(s) found for: Gram-Positive Bacterial Infections. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2015-002218-60 Sponsor Protocol Number: 0101 Start Date*: 2015-07-03
    Sponsor Name:Theravance Biopharma Antibiotics, Inc.
    Full Title: An Open-Label Study of the Pharmacokinetics of a Single Dose of Telavancin in Pediatric Subjects Aged 1 to 17 Years
    Medical condition: Gram-Positive Bacterial Infections
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10053021 Gram-positive bacterial infection LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2013-005415-26 Sponsor Protocol Number: TMC-ORI-11-01 Start Date*: 2015-03-19
    Sponsor Name:Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of Oritavancin Single Dose Infusion in Pediatric Subjects Less Than 18 Years of Age with Suspected or Confirmed Bacteri...
    Medical condition: Gram positive bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2020-004591-17 Sponsor Protocol Number: ICD-01 Start Date*: 2021-04-23
    Sponsor Name:Mikrobiomik Healthcare Company S.L.
    Full Title: A randomised, controlled, open-label phase III clinical trial in patients with recurrent Clostridioides difficile (CD) infection, to evaluate the efficacy and safety of capsules of lyophilised faec...
    Medical condition: Recurrent Clostridioides difficile (CD) infection
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053021 Gram-positive bacterial infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2012-000781-38 Sponsor Protocol Number: PHAO2011/LB/LIZ-BONE Start Date*: 2012-10-08
    Sponsor Name:Direction de la recherche clinique du centre hospitalier universitaire de Tours, Bretonneau
    Full Title: Prospective, Randomized, open label, European, multicenter study of the efficacy of the linezolid-rifampin combination versus standard of care in the treatment of Gram-positive prosthetic hip joint...
    Medical condition: Hip prosthesis infected by gram-positive bacteria
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) IT (Completed)
    Trial results: (No results available)
    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: 2014-004628-23 Sponsor Protocol Number: M000507_6004 Start Date*: 2015-03-17
    Sponsor Name:Sanofi
    Full Title: Comparison of Teicoplanin and Vancomycin in Terms of Efficacy and Side Effect Profile During Initial Antibiotic Treatment of Febrile Neutropenic Patients at High Risk For Gram-Positive Infection: M...
    Medical condition: Neutropenic and febrile patients with hematological or solid tumors, who are at high risk for gram-positive bacterial infection.
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2012-001496-36 Sponsor Protocol Number: AMPISUL/AMOXICLAV-HD_V1.4 Start Date*: 2013-07-19
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme
    Full Title: Multiple-dose pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis in longterm haemodialysis patients
    Medical condition: Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    14.1 10021881 - Infections and infestations 10035649 Pneumococcal secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10004038 Bacterial infection due to streptococcus, group C LLT
    14.1 10021881 - Infections and infestations 10004039 Bacterial infection due to streptococcus, group D LLT
    16.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    14.1 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    14.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    14.1 10021881 - Infections and infestations 10004042 Bacterial infection due to unspecified streptococcus LLT
    14.1 10021881 - Infections and infestations 10004037 Bacterial infection due to streptococcus, group B LLT
    14.1 10021881 - Infections and infestations 10054278 Bacterial infection due to streptococcus, group F LLT
    14.1 10021881 - Infections and infestations 10004041 Bacterial infection due to unspecified staphylococcus LLT
    14.1 10021881 - Infections and infestations 10004036 Bacterial infection due to streptococcus, group A LLT
    14.1 10021881 - Infections and infestations 10004044 Bacterial infection NOS LLT
    14.1 10021881 - Infections and infestations 10004035 Bacterial infection due to staphylococcus aureus LLT
    14.1 10021881 - Infections and infestations 10004040 Bacterial infection due to streptococcus, group G LLT
    14.1 10021881 - Infections and infestations 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    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: 2013-004154-22 Sponsor Protocol Number: TR701-132 Start Date*: 2014-04-17
    Sponsor Name:Trius Therapeutics, a Wholly Owned Subsidiary of Cubist Pharmaceuticals, Inc.
    Full Title: A Phase 3 Randomized Double-blind Study Comparing TR 701 FA and Linezolid in Ventilated Gram-positive Nosocomial Pneumonia
    Medical condition: Ventilated Gram-positive nosocomial pneumonia
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004862 10052596 Nosocomial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) AT (Completed) DE (Completed) BE (Completed) ES (Completed) GR (Completed) SK (Completed) CZ (Completed) EE (Completed) GB (Completed) HR (Completed) PT (Completed) IT (Prematurely Ended)
    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: 2012-005738-12 Sponsor Protocol Number: LIPSTIC.V.01 Start Date*: 2013-03-27
    Sponsor Name:Alder Hey Children's NHS Foundation Trust
    Full Title: Liverpool Pharmacokinetic/pharmacodynamics study of teicoplanin in children (LIPSTIC).
    Medical condition: Gram-positive bacterial infection: late-onset neonatal sepsis, central line-associated blood stream infection, ventilator-associated pneumonia.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    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: 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: 2021-003670-31 Sponsor Protocol Number: BC-10433 Start Date*: 2021-09-22
    Sponsor Name:Ghent University Hospital
    Full Title: Impact of Model-Informed Precision Dosing of Vancomycin in Adults: A randomized, controlled clinical trial
    Medical condition: Gram positive infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    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
    EudraCT Number: 2012-005127-33 Sponsor Protocol Number: UGENT_LIMOP Start Date*: 2013-01-11
    Sponsor Name:University Ghent
    Full Title: Pharmacokinetic and pharmacodynamic evaluation of linezolid administered intravenously in MRSA-positive, morbidly obese patients with pneumonia.
    Medical condition: MRSA-positive, morbidly obese patients with pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10053024 Pneumonia gram-positive bacterial LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004399-11 Sponsor Protocol Number: 380204 Start Date*: 2006-12-11
    Sponsor Name:Medinova AG
    Full Title: The Efficacy of 10 mg Dequalinium Chloride (Fluomizin®) in the Local Treatment of Aerobic Bacterial Vaginal Infections in Comparison to Placebo
    Medical condition: Aerobic Bacterial Vaginal Infection
    Disease: Version SOC Term Classification Code Term Level
    8.1 10046914 Vaginal infection LLT
    Population Age: Adults Gender: Female
    Trial protocol: DE (Completed) AT (Prematurely Ended) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-005159-32 Sponsor Protocol Number: A5951105 Start Date*: 2005-04-28
    Sponsor Name:Pfizer Limited
    Full Title: Linezolid vs Vancomycin/Cefazolin in the treatment of hemodialysis patients with catheter-related gram-positive bloodstream infections
    Medical condition: Catheter-related Gram-positive bloodstream infections.
    Disease: Version SOC Term Classification Code Term Level
    7.1 10007810 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) DE (Prematurely Ended) IT (Prematurely Ended) ES (Completed)
    Trial results: View results
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