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Clinical trials for Antimicrobial drugs

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   44364   clinical trials with a EudraCT protocol, of which   7388   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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    13 result(s) found for: Antimicrobial drugs. Displaying page 1 of 1.
    EudraCT Number: 2013-002148-95 Sponsor Protocol Number: SHORTEN Start Date*: 2014-05-21
    Sponsor Name:Fundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
    Full Title: Optimal duration of the antimicribial treatment for bloodstream infections produced by Enterobacteriaceae. Clinical trial "SHORTEN".
    Medical condition: Adult patients with bloodstream infections produced by Enterobacteriaceae.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-001257-14 Sponsor Protocol Number: P160910J Start Date*: 2018-04-13
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Temocillin versus a carbapenem as initial intravenous treatment for extended-spectrum beta-lactamase related urinary tract infections, a non-inferiority study.TEMO-CARB
    Medical condition: -Hospitalized patient with complicated UTI due to ESBL producing enterobacteriaceae (pyelonephritis, prostatitis or renal abscess) requiring parenteral antimicrobial therapy.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10054088 Urinary tract infection bacterial PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-004677-14 Sponsor Protocol Number: DIABOLO Start Date*: 2018-03-09
    Sponsor Name:Erasmus MC
    Full Title: Dose IndividualizAtion of Beta-lactam and fluOroquinoLone AntiBiotics in ICU patients: to TDM or not to TDM and the effects on Outcome (DIABOLO-study)
    Medical condition: ICU patients with infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    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: 2018-005046-10 Sponsor Protocol Number: HEMSC42 Start Date*: 2019-07-23
    Sponsor Name:Radboud university medical center
    Full Title: Anakinra: Efficacy of interleukin-1 pathway inhibitor anakinra for the management of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic s...
    Medical condition: Febrile neutropenia and mucositis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004867 10028127 Mucositis LLT
    20.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004981-85 Sponsor Protocol Number: CD101.IV.3.08 Start Date*: 2020-04-06
    Sponsor Name:Cidara Therapeutics, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Double-Blind Study of the Efficacy and Safety of Rezafungin for Injection Versus the Standard Antimicrobial Regimen to Prevent Invasive Fungal Diseases in Adults...
    Medical condition: Invasive Fungal Diseases in Adults undergoing Allogeneic Blood and Marrow Transplantation (BMT)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10017528 Fungal infectious disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) BE (Trial now transitioned) NL (Ongoing) GB (GB - no longer in EU/EEA) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002216-14 Sponsor Protocol Number: 1277 Start Date*: 2017-07-26
    Sponsor Name:Clinical Pharmacology, MUV
    Full Title: Investigation of Pharmacokinetic of Antiinfective Therapy in Healthy Subjects and Severely Burned Patients Admitted to the ICU
    Medical condition: This is an exploratory pharmacokinetic trial in healthy volunteers (cohort A) and patients with severe burns admitted to the ICU (cohort B). The Information retrieved by these investigations will h...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004419-11 Sponsor Protocol Number: SC35 Start Date*: 2017-04-20
    Sponsor Name:Radboud university medical center
    Full Title: Safety and efficacy of interleukin-1 inhibitor anakinra for the amelioration of fever during neutropenia and mucositis in patients with multiple myeloma receiving an autologous hematopoietic stem c...
    Medical condition: Mucositis and febrile neutropenia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004867 10028127 Mucositis LLT
    19.0 10005329 - Blood and lymphatic system disorders 10016288 Febrile neutropenia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-004108-16 Sponsor Protocol Number: HOFATA_v3.0 Start Date*: 2022-04-21
    Sponsor Name:Medical University Vienna
    Full Title: Host factors predicting target site concentration of antibiotics in critically ill patients: An explorative pharmacokinetic biomarker study
    Medical condition: All patients given standard of care intravenous therapy of the studied antibiotics will be screened against the inclusion criteria. Two groups are included: Group A (septic patients with organ dysf...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-007024-34 Sponsor Protocol Number: Stom2009 Start Date*: 2009-12-28
    Sponsor Name:General Teaching Hospital
    Full Title: Treatment of alveolar osteitis using ozonated water
    Medical condition: Complication after tooth extraction - alveolar osteitis (dry socket). There is no causal treatment of alveolar osteitis. That’s why symptomatic therapy is used. Disinfectants are the most important...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10013787 Dry socket LLT
    12.0 10013787 Dry socket LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-003633-24 Sponsor Protocol Number: UITB-Study-29 Start Date*: 2009-01-08
    Sponsor Name:TB Investigation Unit of Barcelona
    Full Title: Evaluation of a rifapentine-containing regimen for intensive phase treatment of pulmonary tuberculosis Evaluación de una Pauta con Rifapentina para la Fase Intensiva del tratamiento de la Tub...
    Medical condition: To compare two treatments for Pulmonary Tuberculosis Comparar dos tratamientos para la tuberculosis pulmonar
    Disease: Version SOC Term Classification Code Term Level
    9.1 10037440 Pulmonary tuberculosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-003933-27 Sponsor Protocol Number: POL7080-011 Start Date*: 2018-01-29
    Sponsor Name:Polyphor Ltd.
    Full Title: A multicenter, open-label, randomized, active-controlled, parallel group, pivotal study to investigate the efficacy, safety and tolerability, and pharmacokinetics of murepavadin combined with one a...
    Medical condition: Ventilator-associated bacterial pneumonia (VABP)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10065153 Ventilator associated pneumonia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) EE (Prematurely Ended) ES (Prematurely Ended) FR (Prematurely Ended) HR (Completed) GR (Prematurely Ended) RO (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-003648-55 Sponsor Protocol Number: EZH-301 Start Date*: 2020-08-17
    Sponsor Name:Epizyme, Inc.
    Full Title: A Phase 1b/3 Global, Randomized, Double-blind, Placebo-Controlled Trial of Tazemetostat in Combination With Doxorubicin as Frontline Therapy for Advanced Epithelioid Sarcoma
    Medical condition: Phase 1b: Have histologically confirmed Soft tissue sarcoma (STS). Phase 3: Morphology and immunophenotypic panel consistent with epithelioid sarcoma (eg, CD34, epithelial membrane antigen [EMA], ...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10015100 Epithelioid sarcomas HLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10075333 Soft tissue sarcoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) BE (Completed) PL (Completed)
    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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