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Clinical trials for Neonatal sepsis

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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    The EU Clinical Trials Register currently displays   44334   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 ).  
     
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    57 result(s) found for: Neonatal sepsis. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2009-011346-26 Sponsor Protocol Number: MAB-N007 Start Date*: 2009-11-27
    Sponsor Name:Biosynexus Incorporated
    Full Title: Ensayo de fase 2b/3, multicéntrico, aleatorizado, doble ciego, controlado con placebo, para evaluar la seguridad y eficacia de Pagibaximab Inyectable en recién nacidos con peso de nacimiento muy ba...
    Medical condition: Prevención de la septicemia causada por estafilococos en recién nacidos con peso de nacimiento muy bajo.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10040049 Sepsis neonatal LLT
    12.0 10056430 Staphylococcal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) GB (Completed) DE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002020-33 Sponsor Protocol Number: OZBS32.18194 Start Date*: 2019-12-10
    Sponsor Name:Erasmus University Medical Center
    Full Title: Pentoxifylline dose optimization in neonatal sepsis.
    Medical condition: Neonatal late onset sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002926-35 Sponsor Protocol Number: 080716CT Start Date*: 2017-01-16
    Sponsor Name:Alder Hey Children's Foundation NHS Trust
    Full Title: Pharmacokinetics of post-operative Cefuroxime in infants undergoing cardiac surgery
    Medical condition: post operative paediatric cardiac patients
    Disease: Version SOC Term Classification Code Term Level
    19.1 10021881 - Infections and infestations 10053840 Bacterial sepsis PT
    Population Age: 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: 2022-001837-35 Sponsor Protocol Number: BPR-PIP-003 Start Date*: 2023-02-27
    Sponsor Name:Basilea Pharmaceutica International Ltd, Allschwil
    Full Title: A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety, pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-term neonates and infants up to 3 months ...
    Medical condition: Late-onset sepsis (LOS) in term and pre-term neonates and infants up to 3 months of age.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: LT (Completed) LV (Prematurely Ended) SK (Completed) PL (Completed) Outside EU/EEA EE (Completed) BG (Completed) DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-000203-89 Sponsor Protocol Number: NeoVanc Start Date*: 2016-07-18
    Sponsor Name:Fondazione PENTA Onlus
    Full Title: Multi-centre, randomised, open label, phase IIb study to compare the efficacy, safety and pharmacokinetics (PK) of an optimised dosing to a standard dosing regimen of vancomycin in neonates and inf...
    Medical condition: Neonatal late onset sepsis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) IT (Prematurely Ended) EE (Prematurely Ended) ES (Prematurely Ended) GR (Prematurely Ended)
    Trial results: (No results available)
    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: 2013-003111-22 Sponsor Protocol Number: V98_21 Start Date*: 2014-11-06
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase II, Randomized, Comparative, Observer-Blind, Multi-Center Study Evaluating the Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyop...
    Medical condition: Healthy person immune response to Group B Streptococcus polysaccharide capsule antigens
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10053588 Group B streptococcus neonatal sepsis PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2004-002170-34 Sponsor Protocol Number: 2004-002170-34 Start Date*: 2006-03-29
    Sponsor Name:Cambridge University Hospital (Addenbrookes Hospital)
    Full Title: "Ensayo clínico controlado randomizado sobre el tratamiento precoz con insulina en recién nacidos de muy bajo peso"
    Medical condition: Very low birth weight infants requiring intensive care have relative insulin deficiency often leading to hyperglycaemia during the first week of life. There is increasing evidence that the early po...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2019-003341-15 Sponsor Protocol Number: FFIS/2019/01/AS Start Date*: 2022-10-21
    Sponsor Name:Fundación para la Formación e Investigación Sanitarias de la Región de Murcia (FFIS)
    Full Title: Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial.
    Medical condition: Pre-eclampsia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10036585 - Pregnancy, puerperium and perinatal conditions 10036485 Pre-eclampsia PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing) AT (Ongoing) DK (Trial now transitioned) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2018-004482-14 Sponsor Protocol Number: P160917 Start Date*: 2019-08-14
    Sponsor Name:ASSISTANCE PUBLIQUE-HOPITAUX DE PARIS (AP-HP)
    Full Title: Tocolysis in the management of preterm premature rupture of membranes before 34 weeks of gestation: a double-blinded randomized controlled trial
    Medical condition: Pregnant women with PPROM at 22 to 33 weeks gestation
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-003094-15 Sponsor Protocol Number: V98_06E1 Start Date*: 2016-02-11
    Sponsor Name:GlaxoSmithKline Biologicals S.A.
    Full Title: A Phase 2, Non-Randomized, Controlled, Open-Label, Parallel-Group, Extension Study to Evaluate the Immunogenicity and Safety of the Second Dose of GBS Trivalent Vaccine in Healthy Non-pregnant Subj...
    Medical condition: Healthy person immune response to a second dose of Group B Streptococcus polysaccharide capsule antigens
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10053588 Group B streptococcus neonatal sepsis PT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2021-003214-40 Sponsor Protocol Number: MVX0004 Start Date*: 2022-01-13
    Sponsor Name:MinervaX Aps
    Full Title: A multicentre, multinational, parallel group, observer-blind, randomised, placebo-controlled study on the Group B Streptococcus vaccine (GBS-NN/NN2), investigating the immunogenicity and safety of ...
    Medical condition: Prevention of Group B Streptococcus infection in neonates.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10053588 Group B streptococcus neonatal sepsis PT
    Population Age: Newborns, Infants and toddlers, Under 18, Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-005180-16 Sponsor Protocol Number: FFIS/2015/02/EV Start Date*: 2016-09-08
    Sponsor Name:Fundación para la Formación e Investigación Sanitaria
    Full Title: Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial.
    Medical condition: Spontaneous preterm birth in twin pregnancies.
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10023555 Labour premature LLT
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed) ES (Completed) BG (Completed) IT (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    EudraCT Number: 2017-001007-72 Sponsor Protocol Number: 80-84800-98-41027 Start Date*: 2017-07-06
    Sponsor Name:Amsterdam UMC location AMC
    Full Title: Atosiban versus placebo in the treatment of late threatened preterm birth (APOSTEL VIII).
    Medical condition: Neonatal outcome in threatened preterm birth between 30 and 34 weeks of gestation.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2008-007498-19 Sponsor Protocol Number: COL-1620-302 Start Date*: 2009-09-17
    Sponsor Name:Columbia Laboratories, Inc
    Full Title: The Effect of Vaginal Progesterone Administration in the prevention of Preterm Birth in Women with Short Cervix, [also Known as: Vaginal progesterone bioadhesive gel (Prochieve)® Extending Gestatio...
    Medical condition: Preterm birth (less than or equal to 32 6/7 weeks gestation)
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005987-15 Sponsor Protocol Number: The Triple P study Start Date*: 2009-10-22
    Sponsor Name:AMC Amsterdam
    Full Title: Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.
    Medical condition: Preterm birth with healthy singleton pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-000174-66 Sponsor Protocol Number: APOSTELIV Start Date*: 2012-02-07
    Sponsor Name:Academic Medical Centre
    Full Title: Assessment of Perinatal Outcome by uSe of Tocolysis in Early Labour (APOSTEL IV); Nifedipine versus placebo in the treatment of preterm premature rupture of membranes
    Medical condition: Premature preterm rupture of membranes
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
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    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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