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Clinical trials for Infections and infestations congenital

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   44412   clinical trials with a EudraCT protocol, of which   7421   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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    37 result(s) found for: Infections and infestations congenital. Displaying page 1 of 2.
    1  2  Next»
    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: 2015-003405-42 Sponsor Protocol Number: 201532 Start Date*: 2018-01-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, open-label, single-group, multi-centre study to assess the immunogenicity, safety and reactogenicity of GSK Biologicals’ combined reduced antigen content diphtheria, tetanus and acellu...
    Medical condition: Healthy volunteers [Booster immunisation against diphtheria, tetanus and pertussis diseases of individuals from age of four years onwards. The study population for this study will include individua...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2021-004590-30 Sponsor Protocol Number: R10933-10987-COV-2121 Start Date*: 2022-09-23
    Sponsor Name:Regeneron Pharmaceuticals Inc.
    Full Title: A Phase 2a, Open-Label Study Assessing Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Single-Dose Subcutaneous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab and Imdevim...
    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: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000535-23 Sponsor Protocol Number: HCB/2021/0060 Start Date*: 2022-06-20
    Sponsor Name:Barcelona Institute for Global Health (ISGlobal)
    Full Title: Efficacy of low dose acetylsalicylic acid in preventing adverse maternal and perinatal outcomes in SARS-CoV-2 infected pregnant women
    Medical condition: SARS-CoV-2 infection
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004952-80 Sponsor Protocol Number: A0661158 Start Date*: 2015-04-03
    Sponsor Name:Pfizer Inc
    Full Title: Phase 3, Open-Label, Randomized, Comparative Study to Evaluate Azithromycin plus Chloroquine and Sulfadoxine plus Pyrimethamine Combinations for Intermittent Preventive Treatment of Falciparum Mala...
    Medical condition: Intermittent Preventive Treatment In Pregnancy (IPTp)
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-001441-40 Sponsor Protocol Number: SC-Ta1-CF-001 Start Date*: 2019-12-17
    Sponsor Name:SciClone Pharmaceuticals Limited Ltd
    Full Title: A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients.
    Medical condition: Cystic Fibrosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    20.0 10021881 - Infections and infestations 10021881 Infections and infestations SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-004491-31 Sponsor Protocol Number: M12-420 Start Date*: 2015-02-03
    Sponsor Name:Abbott Japan Co., Ltd
    Full Title: Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions
    Medical condition: Respiratory Syncytial Virus Infection
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-001832-27 Sponsor Protocol Number: AT-202 Start Date*: 2023-01-20
    Sponsor Name:Allecra Therapeutics SAS
    Full Title: A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Part...
    Medical condition: Complicated urinary tract infections including acute pyelonephritis
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10037597 Pyelonephritis acute PT
    20.0 10021881 - Infections and infestations 10046577 Urinary tract infections HLT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) HU (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) SK (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    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: 2011-001362-18 Sponsor Protocol Number: GS-US-205-0160 Start Date*: 2012-03-19
    Sponsor Name:Gilead Sciences, Inc.
    Full Title: Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chron...
    Medical condition: cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10068288 Cystic fibrosis pulmonary exacerbation LLT
    14.1 10021881 - Infections and infestations 10070608 Infective pulmonary exacerbation of cystic fibrosis PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-015953-18 Sponsor Protocol Number: DORIPED3002 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infec...
    Medical condition: Complicated Urinary Tract Infections
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10046571 Urinary tract infection PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) CZ (Completed) PL (Temporarily Halted) LV (Prematurely Ended) DE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-001862-56 Sponsor Protocol Number: 64041575RSV2004 Start Date*: 2018-01-09
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered Lumicitabine (...
    Medical condition: Respiratory syncytial virus infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended) BE (Prematurely Ended) FI (Prematurely Ended) SK (Prematurely Ended) ES (Prematurely Ended) IE (Prematurely Ended) PT (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001671-35 Sponsor Protocol Number: MI-CP124 Start Date*: 2005-08-16
    Sponsor Name:MedImmune, Inc.
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Childr...
    Medical condition: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).
    Disease: Version SOC Term Classification Code Term Level
    7.0 10061603 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) GB (Completed) SE (Completed) CZ (Prematurely Ended) BE (Completed) DE (Completed) DK (Completed) AT (Prematurely Ended) ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2021-000623-13 Sponsor Protocol Number: VIR-7831-5008 Start Date*: 2021-07-29
    Sponsor Name:Vir Biotechnology, Inc.
    Full Title: A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the...
    Medical condition: Mild/moderate COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    23.1 10021881 - Infections and infestations 10084401 COVID-19 respiratory infection LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing) AT (Completed) IT (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-005799-41 Sponsor Protocol Number: LOC/11-17-ATCF Start Date*: 2012-10-04
    Sponsor Name:CHU de Rennes (Rennes University Hospital Centre)
    Full Title: Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and of voriconazole in patients with cystic fibrosis and presenting with persistent positive sputums for Aspergillus
    Medical condition: Cystic fibrosis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10011762 Cystic fibrosis PT
    14.1 10021881 - Infections and infestations 10003486 Aspergillus infections HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-005444-35 Sponsor Protocol Number: C4591015 Start Date*: 2021-04-15
    Sponsor Name:BioNTech SE
    Full Title: A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEAL...
    Medical condition: Protection against COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: View results
    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: 2009-016069-27 Sponsor Protocol Number: DORIPED3003 Start Date*: 2010-05-28
    Sponsor Name:Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
    Full Title: A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia
    Medical condition: Bacterial Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10004051 Bacterial pneumonia, unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) LV (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-002070-61 Sponsor Protocol Number: MI-CP124-S2 Start Date*: 2007-09-04
    Sponsor Name:MedImmune, LLC
    Full Title: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of MEDI-524, a Humanized Enhanced Potency Monoclonal Antibody Against Respiratory Syncytial Virus (RSV), in Childr...
    Medical condition: Serious respiratory syncytial virus (RSV) disease in children with hemodynamically significant congential heart disease (CHD).
    Disease: Version SOC Term Classification Code Term Level
    9.0 10061603 PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) AT (Completed) SE (Completed) BE (Completed) HU (Completed) DE (Completed) FR (Completed) PL (Completed) CZ (Completed) Outside EU/EEA
    Trial results: View results
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