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Clinical trials for Rickettsiales

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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    • 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 ).  
     
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    4 result(s) found for: Rickettsiales. Displaying page 1 of 1.
    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: 2013-001997-18 Sponsor Protocol Number: ACHN-490-007 Start Date*: 2014-02-25
    Sponsor Name:Achaogen, Inc.
    Full Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriace...
    Medical condition: Bloodstream infections (BSI) and nosocomial pneumonia due to carbapenem-resistant Enterobacteriaceae (CRE)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Prematurely Ended) IT (Completed) DE (Completed) FR (Completed)
    Trial results: View results
    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: 2012-001496-36 Sponsor Protocol Number: AMPISUL/AMOXICLAV-HD_V1.4 Start Date*: 2013-07-19
    Sponsor Name:Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Klinische abteilung für Infektionen und Tropenme
    Full Title: Multiple-dose pharmacokinetics of ampicillin / sulbactam and amoxicillin / clavulanic acid during haemodialysis in longterm haemodialysis patients
    Medical condition: Suspected or proven bacterial infection requiring therapy with broad spectrum antibiotics
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10053021 Gram-positive bacterial infection LLT
    14.1 10021881 - Infections and infestations 10035649 Pneumococcal secondary bacterial infection of acute bronchitis LLT
    14.1 10021881 - Infections and infestations 10004038 Bacterial infection due to streptococcus, group C LLT
    14.1 10021881 - Infections and infestations 10004039 Bacterial infection due to streptococcus, group D LLT
    16.0 10021881 - Infections and infestations 10004031 Bacterial infection due to other gram-negative organisms LLT
    14.1 10021881 - Infections and infestations 10004047 Bacterial infections NEC HLT
    14.1 10021881 - Infections and infestations 10060945 Bacterial infection PT
    14.1 10021881 - Infections and infestations 10004042 Bacterial infection due to unspecified streptococcus LLT
    14.1 10021881 - Infections and infestations 10004037 Bacterial infection due to streptococcus, group B LLT
    14.1 10021881 - Infections and infestations 10054278 Bacterial infection due to streptococcus, group F LLT
    14.1 10021881 - Infections and infestations 10004041 Bacterial infection due to unspecified staphylococcus LLT
    14.1 10021881 - Infections and infestations 10004036 Bacterial infection due to streptococcus, group A LLT
    14.1 10021881 - Infections and infestations 10004044 Bacterial infection NOS LLT
    14.1 10021881 - Infections and infestations 10004035 Bacterial infection due to staphylococcus aureus LLT
    14.1 10021881 - Infections and infestations 10004040 Bacterial infection due to streptococcus, group G LLT
    14.1 10021881 - Infections and infestations 10018657 Gram-negative bacterial infection NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (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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