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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   44020   clinical trials with a EudraCT protocol, of which   7318   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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    133 result(s) found for: Infections. Displaying page 1 of 7.
    1  2  3  4  5  6  7  Next»
    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: 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: 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: 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: 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: 2018-002742-37 Sponsor Protocol Number: 66735.041.18 Start Date*: 2018-09-12
    Sponsor Name:University Medical Center Utrecht
    Full Title: Effect of intranasal administration of palivizumab on respiratory syncytial virus-associated infection – a randomized controlled trial
    Medical condition: respiratory syncytial virus infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001169-18 Sponsor Protocol Number: UoL001360 Start Date*: 2018-10-15
    Sponsor Name:University Of Liverpool
    Full Title: The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study.
    Medical condition: Critical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    20.1 10021881 - Infections and infestations 10065188 Lower respiratory tract infection viral PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-003087-20 Sponsor Protocol Number: 800_OPBG_2014 Start Date*: 2014-11-12
    Sponsor Name:IRCCS Ospedale Pediatrico Bambino Gesù
    Full Title: Determination of Plasmatic and CSF Levels Of High Doses Of Micafungin in Neonates Suffering from Systemic Candidiasis and/or Candida meningitis.
    Medical condition: Systemic Candidiasis and/or Candida Meningitis
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004862 10027238 Meningitis fungal NOS LLT
    17.0 100000004852 10027237 Meningeal fungal infections HLT
    17.0 100000004862 10042941 Systemic fungal infection NOS LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003842-34 Sponsor Protocol Number: MK-5592-127 Start Date*: Information not available in EudraCT
    Sponsor Name:Merck Sharp & Dohme LLC
    Full Title: A Phase 2, Open-Label, Single-Arm, Sequential-Panel Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Posaconazole (POS, MK-5592) Intravenous and Powder for Oral Suspension Formul...
    Medical condition: Invasive Fungal Infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10017533 Fungal infection PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) Outside EU/EEA BE (Trial now transitioned) GR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2009-016608-22 Sponsor Protocol Number: PHRCIR09-DrTOURNEUX Start Date*: 2010-01-27
    Sponsor Name:CHU AMIENS
    Full Title: Administration de Surfactant précoce : Evaluation chez le Nouveau-né ≥ 35 semaines d’aménorrhée présentant une détresse respiratoire
    Medical condition: Détresse respiratoire du nouveau-né entre 35 et 41 semaines d'aménorrhées
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    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: 2013-003611-21 Sponsor Protocol Number: 2013-003611-21 Start Date*: 2013-12-20
    Sponsor Name:Karolinska Institutet
    Full Title: Safety of fluconazol treatment of premature and full-term newborns - a study on interactions by NSAIDs with fluconazole in respect of pharmacodynamic endpoints with urinary excretion of vas...
    Medical condition: Fungal infection prophylaxis Patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    16.1 10021881 - Infections and infestations 10028924 Neonatal candida infection PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-000608-14 Sponsor Protocol Number: 1.0/170119 Start Date*: Information not available in EudraCT
    Sponsor Name:Tartu University Hospital
    Full Title: Prospective validation of individualized Bayesian dose optimization tool DosOpt for Vancomycin treatment in neonates.
    Medical condition: In neonatal population wide inter-and intra-individual variability of pharmacokinetics makes extremely difficult to ensure optimal exposure of vancomycin with standard regimens. On average >50% of ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: EE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002980-25 Sponsor Protocol Number: PRESERV Start Date*: 2020-06-12
    Sponsor Name:OSP.DEGLI INFERMI DI BIELLA
    Full Title: Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV)
    Medical condition: Respiratory sincizial virus (RSV) bronchiolitis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-004538-40 Sponsor Protocol Number: BC-5429 Start Date*: 2020-11-20
    Sponsor Name:Ghent University Hospital
    Full Title: A multicentric randomised controlled clinical trial to study the impact of bedside model-informed precision dosing of vancomycin in critically ill children.
    Medical condition: Gram positive infection
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-001113-21 Sponsor Protocol Number: NDPHRECOVERY Start Date*: 2020-03-17
    Sponsor Name:University of Oxford
    Full Title: Randomised Evaluation of COVID-19 Therapy (RECOVERY)
    Medical condition: COVID-19 (infection with SARS-CoV-2 virus)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035737 Pneumonia viral PT
    20.1 10021881 - Infections and infestations 10061982 Severe acute respiratory syndrome PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2015-000874-36 Sponsor Protocol Number: 2014PAED13L Start Date*: 2015-10-30
    Sponsor Name:Norfolk and Norwich University Hospitals NHS Trust
    Full Title: The efficacy and safety of two topical antiseptic solutions for skin disinfection prior to percutaneous central venous catheter insertion in preterm neonates: a feasibility study
    Medical condition: Central venous catheter-related sepsis in premature neonates
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10053212 Catheter sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2007-001430-14 Sponsor Protocol Number: peg-filgrastim Vs filgrastim nel t Start Date*: 2007-02-19
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: Peg-filgrastim Vs filgrastrim in pediatric patients.
    Medical condition: haematologic malignant tumors
    Disease: Version SOC Term Classification Code Term Level
    6.1 10000880 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (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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