Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 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
  • 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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
    Select Country:
    		 Select Age Range:
    Select Trial Status:
    		 Select Trial Phase:
    Select Gender:
    Select Date Range:
    to
    Select Rare Disease:
    IMP with orphan designation in the indication
    Orphan Designation Number:
    Results Status:
    Clear advanced search filters
     
    121 result(s) found for: Infections. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    EudraCT Number: 2007-000468-26 Sponsor Protocol Number: Rit EBV Start Date*: 2007-01-11
    Sponsor Name:OSPEDALE POLICLINICO S. MATTEO
    Full Title: A phase I/II multicentre study to evaluate the safety and efficacy of rituximab (monoclonal antibody anti-CD20) for prevention and/or therapy of EBV-disease.
    Medical condition: NOT AVAILABLE
    Disease: Version SOC Term Classification Code Term Level
    9.1 10015108 Epstein-Barr virus infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    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: 2016-000656-99 Sponsor Protocol Number: REMPEX-507 Start Date*: 2023-09-28
    Sponsor Name:Rempex Pharmaceuticals-Melinta Therapeutics
    Full Title: An Open label, Dose-finding, Pharmacokinetics, Safety, and Tolerability Study of a Single Dose Infusion of VABOMERE® (Meropenem-Vaborbactam) in Pediatric Subjects From Birth to Less Than 18 Years o...
    Medical condition: Suspected or confirmed negative bacterial infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.0 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    20.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2014-003485-24 Sponsor Protocol Number: CXA-PEDS-13-08 Start Date*: 2014-09-25
    Sponsor Name:Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 1, Non-comparative, Open-label Study to Characterize the Pharmacokinetics of a Single Intravenous Dose of Ceftolozane/tazobactam in Pediatric Patients Receiving Standard of Care Antibiotic ...
    Medical condition: This study is designed to assess the PK, safety, and tolerability of a single intravenous dose of ceftolozane/tazobactam in pediatric patients.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    20.0 100000004865 10049086 Antibacterial prophylaxis LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-002198-44 Sponsor Protocol Number: P903-21 Start Date*: 2011-07-22
    Sponsor Name:Cerexa, Inc. (subsidary of Forest Laboratories)
    Full Title: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Medical condition: Pharmacokinetics of a Single Dose of Ceftaroline fosamil in Children Ages Birth to Younger Than 12 Years With Suspected or Confirmed Infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2012-000825-33 Sponsor Protocol Number: MI-CP117 Start Date*: 2012-03-09
    Sponsor Name:MedImmune LLC
    Full Title: A Phase 3 Study of MEDI-524 (Motavizumab) for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States
    Medical condition: Serious Lower Respiratory Tract disease caused by RSV
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-000595-32 Sponsor Protocol Number: Ematonco/divmalinf/2006.1 Start Date*: 2006-09-06
    Sponsor Name:ISTITUTO GIANNINA GASLINI
    Full Title: Rescue therapy for indwelling central venous Hickmann-Broviac catheter related infections with antibiotic lock technique
    Medical condition: Patients with Hemato-oncologic disease or undergoing Hematopoietic stem cell transplantation
    Disease: Version SOC Term Classification Code Term Level
    6.1 10003997 PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-004535-84 Sponsor Protocol Number: R10933-10987-COV-2114 Start Date*: 2022-11-21
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti- Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) f...
    Medical condition: Coronavirus disease 2019
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004447-36 Sponsor Protocol Number: ZonMw848015005 Start Date*: 2017-06-23
    Sponsor Name:Stichting Rotterdams Onderzoeksconsortium Kindergeneeskunde
    Full Title: INTRAVENOUS-TO-ORAL ANTIBIOTIC SWITCH THERAPY FOR SUSPECTED NEONATAL BACTERIAL INFECTIONS: CLINICAL EFFICACY, SAFETY AND COST-EFFECTIVENESS
    Medical condition: Neonatal probable bacterial infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004151-35 Sponsor Protocol Number: PK-1 Start Date*: Information not available in EudraCT
    Sponsor Name:Universität Heidelberg
    Full Title: Pharmacokinetics of oral cefuroxime-axetil compared to intravenous cefuroxime in term neonates and possible adjustment of the oral therapy
    Medical condition: 12 Patients (full term neonates with 7 to 28 days of age) with infections of the skin, the nails or the respiratory tract.
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-019955-23 Sponsor Protocol Number: LWH 0852 Start Date*: 2010-12-29
    Sponsor Name:Liverpool Women's NHS Foundation Trust [...]
    1. Liverpool Women's NHS Foundation Trust
    2. Liverpoool Womens NHS Foundation Trust
    Full Title: To evaluate the pharmakcokinetics, tolerability and short term safety of ciprofloxacin in neonates and infants with suspected (or proven) Gram Negative Infection Open Label pilot PK study - TINN T...
    Medical condition: Pharmacokinetics of ciprofloxacin used for suspected or proven gram negative sepsis.
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-004527-42 Sponsor Protocol Number: W10-664 Start Date*: 2015-02-03
    Sponsor Name:Abbott Laboratories LLC
    Full Title: A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation.
    Medical condition: Severe Respiratory Syncytial Virus Infection (RSV)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-003753-34 Sponsor Protocol Number: CE01-120 Start Date*: 2015-05-08
    Sponsor Name:Cempra Pharmaceuticals, Inc.
    Full Title: A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics (PK) and Safety of Solithromycin as Add-on Therapy in Adolescents and Children with Suspected or Confirmed Bacterial Infe...
    Medical condition: Adolescents and Children with Suspected or Confirmed Bacterial Infection
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BG (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2011-005852-33 Sponsor Protocol Number: CCOA566B2306 Start Date*: 2016-04-11
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, single-arm study to evaluate the efficacy, safety and PK of artemether-lumefantrine Dispersible Tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infant...
    Medical condition: The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with u...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-003717-18 Sponsor Protocol Number: 215226/VIR-7831-5005 Start Date*: 2021-12-30
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: An open-label, non-comparator, multicenter study to describe the pharmacokinetics (PK), pharmacodynamics (PD; viral load) and safety following a single intravenous or intramuscular dose of sotrovim...
    Medical condition: COVID-19 at high risk of disease progression
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GR (Completed)
    Trial results: View results
    EudraCT Number: 2023-000804-21 Sponsor Protocol Number: CCOA566B2307 Start Date*: 2024-07-29
    Sponsor Name:Novartis Pharma AG
    Full Title: Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Ne...
    Medical condition: Plasmodium Falciparum Malaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    20.1 10021881 - Infections and infestations 10035500 Plasmodium falciparum infection PT
    21.1 10021881 - Infections and infestations 10016171 Falciparum malaria LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001515-31 Sponsor Protocol Number: NEOMERO-1 Start Date*: 2011-08-25
    Sponsor Name:FONDAZIONE PENTA ONLUS
    Full Title: EFFICACY, PHARMACOKINETICS AND SAFETY OF MEROPENEM IN INFANTS BELOW 90 DAYS OF AGE (INCLUSIVE) WITH CLINICAL OR CONFIRMED LATE-ONSET SEPSIS: A EUROPEAN MULTICENTER RANDOMISED PHASE III TRIAL
    Medical condition: late onset sepsis in the neonate and infant up to 90 days of age
    Disease: Version SOC Term Classification Code Term Level
    17.0 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) GR (Completed) LT (Completed) ES (Completed)
    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: 2015-004805-17 Sponsor Protocol Number: AC-061A303 Start Date*: 2017-07-12
    Sponsor Name:Actelion Pharmaceuticals Ltd.
    Full Title: A prospective, multicenter study to investigate the pharmacokinetics, safety, and efficacy of cadazolid versus vancomycin in pediatric subjects with Clostridium difficile-associated diarrhea.
    Medical condition: Clostridium difficile-associated diarrhea (CDAD)
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10012734 Diarrhea, Clostridium difficile LLT
    19.1 10021881 - Infections and infestations 10054236 Clostridium difficile infection PT
    19.1 10021881 - Infections and infestations 10022661 Intestinal infection due to clostridium difficile LLT
    19.1 10021881 - Infections and infestations 10012748 Diarrhoea, Clostridium difficile LLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) HU (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  5  6  7  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sun May 11 20:27:55 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA