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Clinical trials for Antimicrobial agent

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   44335   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    17 result(s) found for: Antimicrobial agent. Displaying page 1 of 1.
    EudraCT Number: 2018-003321-29 Sponsor Protocol Number: 17-169 Start Date*: Information not available in EudraCT
    Sponsor Name:RWTH Aachen University represented by the Rector himself, represented by the Dean of the Medical Faculty
    Full Title: Clinical relevance of the antimicrobial resistance testing in the treatment of chronic wounds with antiseptics
    Medical condition: Decubitus, acute or chronic wounds (open wounds existing ≥ 14 days)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-001855-37 Sponsor Protocol Number: OCT02-2006 Start Date*: 2007-05-14
    Sponsor Name:Schülke & Mayr GmbH
    Full Title: Effect of an octenidine-based topical antimicrobial agent (Octenisept) on wound healing of chronic venous leg ulcers: a prospective, twelve-week comparison versus local treatment with Ringer soluti...
    Medical condition: Chronic venous leg ulcers In Germany, approximately three million people suffer from chronic leg ulcers of various origins. These ulcers are often very painful and extremely cost-intensive disease...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10066677 Chronic leg ulcer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) HU (Prematurely Ended) GB (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-004037-10 Sponsor Protocol Number: CE01-119 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A phase 1, open-label, multi-centre study to determine the PK and safety of a 5-day oral dosing of solithromycin as add-on therapy to antimicrobial agent administered to adolescent with suspected o...
    Medical condition: suspected or confirmed bacterial infection
    Disease:
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-006153-41 Sponsor Protocol Number: J&P004/2008 Start Date*: 2009-03-30
    Sponsor Name:Medical university Graz, Department of Plastic Surgery
    Full Title: Target site pharmacokinetics of linezolid after repetitive doses in diabetic patients with bacterial foot infection
    Medical condition: The study population will consist of a representative group of adult male or female patients with documented diabetes and bacterial soft tissue infection of the foot complicated by osteomyelitis. P...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001396-16 Sponsor Protocol Number: OP0595-6 Start Date*: 2023-03-29
    Sponsor Name:Meiji Seika Pharma Co., Ltd.
    Full Title: A Phase 3, Multi-Center, Randomized, Single-Blind Study to Assess the Efficacy and Safety of Cefepime/Nacubactam and Aztreonam/Nacubactam Versus Best Available Therapy in Adults With Complicated Ur...
    Medical condition: Complicated urinary tract infection (cUTI), acute uncomplicated pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), and complicated ...
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004862 10080628 Complicated urinary tract infection LLT
    20.1 100000004862 10079985 Uncomplicated pyelonephritis LLT
    21.1 100000004862 10081414 Ventilator associated bacterial pneumonia LLT
    20.1 100000004862 10079983 Complicated intra-abdominal infection LLT
    21.1 100000004862 10081416 Hospital acquired bacterial pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SK (Trial now transitioned) GR (Trial now transitioned) LV (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004041-26 Sponsor Protocol Number: CE01-120 Start Date*: 2014-10-10
    Sponsor Name:Cempra Pharmaceuticals , Inc
    Full Title: A Phase I, open-label, multi-centre study to evaluate the PK and safety of solithromycin as add-on therapy to antimicrobial agent administered to paediatric subjects with a suspected or confirmed b...
    Medical condition: suspected or confirm bacterial infection
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-004947-65 Sponsor Protocol Number: IMPACT-TDM Start Date*: 2021-05-17
    Sponsor Name:Santiago Grau Cerrato
    Full Title: IMPACT ON THE CLINICAL OUTCOMES AND COST-EFFECTIVENESS OF THE ANTIMICROBIAL THERAPEUTIC MONITORING PROGRAM IN CRITICAL PATIENTS
    Medical condition: - Respiratory infections - Urogenital infections - Abdominal infections
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10056570 Intra-abdominal infection LLT
    20.0 10021881 - Infections and infestations 10038700 Respiratory infection LLT
    20.1 10021881 - Infections and infestations 10065583 Urogenital infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-005112-37 Sponsor Protocol Number: J&P 01/2007 draft4 Start Date*: 2008-08-21
    Sponsor Name:Medizinische Universität Wien, Abteilung für Interne Medizin I
    Full Title: An randomized, controlled, investigator-blinded, prospective, mono-centre study to evaluate the efficacy of fosfomycin versus meropenem in patients with complicated urinary tract infections
    Medical condition: This study will primarily address the question of the efficacy of intravenous fosfomycin 4 g b.i.d. in the therapy of patients presenting with complicated urinary tract infection. These data will b...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10046571 Urinary tract infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-002677-57 Sponsor Protocol Number: PREVAN Start Date*: 2021-11-04
    Sponsor Name:Dra. Julia Origüen Sabater
    Full Title: A phase III, multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of oral vancomycin versus placebo in preventing relapse of Clostridioides difficile infection i...
    Medical condition: Patients at high risk of recurrence due to CDI who require hospitalization and who increase morbidity and mortality from new CDI.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004862 10072994 Clostridium difficile infection recurrence LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-004880-29 Sponsor Protocol Number: HUB-INF-RADICAP Start Date*: 2019-10-02
    Sponsor Name:Dr. Jordi Carratalà Fernández (Servicio de Enfermedades Infecciosas) del Hospital Universitario de Bellvitge
    Full Title: Phase IV randomized, controlled, open and multicentre clinical trial with two parallel groups, to assess the impact of integral molecular tests in the antimicrobial use in community-acquired pneumo...
    Medical condition: Community-acquired pneumonia (CAP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10035664 Pneumonia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-022128-63 Sponsor Protocol Number: LX211-11 Start Date*: 2011-03-16
    Sponsor Name:Lux Biosciences, Inc.
    Full Title: A Multi-center, Double-Masked, Parallel Group, Placebo-Controlled Study to Assess the Efficacy and Safety of Voclosporin as Therapy in Subjects with Active Non-Infectious Uveitis Involving the Inte...
    Medical condition: Non-Infectious Intermediate, Posterior or Pan-uveitis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) IT (Completed) GB (Completed) NL (Ongoing) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000546-30 Sponsor Protocol Number: Rempex-506 Start Date*: 2015-04-21
    Sponsor Name:Rempex Pharmaceuticals, Inc.
    Full Title: A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTERO...
    Medical condition: serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), complicated intra-abdominal infections (cIAI), hospital acquired bacterial pneumonia (HABP...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10003999 Bacteremia LLT
    18.0 100000004862 10001032 Acute pyelonephritis LLT
    18.0 100000004862 10056570 Intra-abdominal infection LLT
    18.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    18.0 100000004862 10046577 Urinary tract infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) IT (Completed) ES (Completed) GR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-005169-63 Sponsor Protocol Number: NAB-BC-3781-3101 Start Date*: 2016-01-12
    Sponsor Name:Nabriva Therapeutics AG
    Full Title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Lefamulin (BC 3781) Versus Moxifloxacin (With or Without Adjunctive Linezolid) in Adults With Community...
    Medical condition: Community-Acquired Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) LV (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2010-019984-12 Sponsor Protocol Number: AMNCH-TCD-CHG-1-2010 Start Date*: 2010-07-21
    Sponsor Name:Adelaide & Meath Hospital, incorporating The National Children's Hospital
    Full Title: A multicentre randomised trial comparing the effects of 2% chlorhexidine gluconate in 70% isopropyl alcohol as a skin, exit site and catheter hub cleansing agent versus other forms of chlorhexidine...
    Medical condition: Prevention of central venous catheter-related infections in haemodialysis patients. This trial will evaluate the effectiveness of 2% chlorhexidine gluconate in 70%isopropyl alcohol as a skin, exit...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: (No results available)
    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: 2022-002636-31 Sponsor Protocol Number: APHP211034 Start Date*: 2022-09-15
    Sponsor Name:Assistance Publique Hôpitaux de Paris/DRCI
    Full Title: Piperacillin-tazobactam and temocillin as carbapenem-alternatives for the treatment of severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae in the in...
    Medical condition: severe infections due to extended-spectrum beta-lactamase–producing Gram-negative Enterobacteriaceae
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-004782-92 Sponsor Protocol Number: NAB-BC-3781-3102 Start Date*: 2016-07-26
    Sponsor Name:Nabriva Therapeutics AG
    Full Title: A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC-3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia
    Medical condition: Community-acquired bacterial pneumonia (CABP) is a commonly occurring serious infection that requires systemic antibiotic therapy and is associated with substantial morbidity, mortality, and consid...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) ES (Completed) BG (Completed)
    Trial results: View results
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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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