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Clinical trials for Clavulanate potassium

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 ).  
     
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    18 result(s) found for: Clavulanate potassium. Displaying page 1 of 1.
    EudraCT Number: 2015-004874-13 Sponsor Protocol Number: AUG102821 Start Date*: 2016-08-03
    Sponsor Name:GlaxoSmithKline
    Full Title: An open label study to determine the pharmacokinetic profiles of amoxicillin and clavulanate in adolescent patients weighing at least 40kg and no more than 16 years of age receiving AUGMENTIN™XR ...
    Medical condition: acute bacterial sinusitis
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004907-22 Sponsor Protocol Number: AUG117150 Start Date*: 2016-08-03
    Sponsor Name:Medicines Development (Infectious Diseases)
    Full Title: A multicenter, open-label study to assess the efficacy and safety of potassium clavulanate/amoxicillin (CVA/AMPC 1:14 combination) in the treatment of [Japanese] children with acute bacterial rhin...
    Medical condition: Acute Bacterial Rhinosinusitis
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001665-33 Sponsor Protocol Number: Koti Start Date*: 2012-06-14
    Sponsor Name:Päijät-Häme Central Hospital
    Full Title:
    Medical condition: Otitis media acuta
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-003773-34 Sponsor Protocol Number: IT001-303 Start Date*: 2018-11-23
    Sponsor Name:Iterum Therapeutics International Limited
    Full Title: A prospective Phase 3, double-blind, multicenter, randomized study of the efficacy and safety of sulopenem followed by sulopenem etzadroxil with probenecid versus ertapenem followed by ciprofloxaci...
    Medical condition: Complicated intra-abdominal infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) BG (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2005-004250-28 Sponsor Protocol Number: 3074A1-900 Start Date*: 2006-09-22
    Sponsor Name:Wyeth Pharmaceuticals, Inc.
    Full Title: A MULTICENTER, RANDOMIZED, OPEN-LABEL COMPARISON OF THE SAFETY AND EFFICACY OF TIGECYCLINE WITH THAT OF AMPICILLIN-SULBACTAM OR AMOXICILLIN-CLAVULANATE TO TREAT COMPLICATED SKIN AND SKIN STRUCTURE ...
    Medical condition: COMPLICATED SKIN AND SKIN STRUCTURE INFECTION
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) FR (Completed) IT (Completed) PT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-003772-31 Sponsor Protocol Number: IT001-302 Start Date*: 2018-12-07
    Sponsor Name:Iterum Therapeutics International Limited
    Full Title: A prospective, Phase 3, randomized, multi-center, double-blind, double dummy study of the efficacy, tolerability and safety of intravenous sulopenem followed by oral sulopenem-etzadroxil with probe...
    Medical condition: Complicated urinary tract infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) HU (Completed) EE (Completed) CZ (Completed) BG (Completed) SK (Completed) HR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-005663-34 Sponsor Protocol Number: EC20081 Start Date*: 2009-06-26
    Sponsor Name:Joseba Andoni Santamaría Zuazua
    Full Title: Ensayo clínico sobre la eficacia de una pauta con amoxicilina/clavulánico 2000/125 mg (GE) cada doce horas, frente a placebo(GC) en la prevención de la infeccion postoperatoria tras la exodoncia de...
    Medical condition: prevención de la infección postoperatorioa tras la exodoncia de terceros molares totalmente incluidos recubiertos por hueso mandibular
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-002536-13 Sponsor Protocol Number: 2014_05 Start Date*: 2016-07-25
    Sponsor Name:Centre Hospitalier Régional et Universitaire de Lille
    Full Title: Evaluation of the efficacy of antibiotic therapy combined with corticosteroids in severe alcoholic hepatitis
    Medical condition: K70.1 (Severe Alcoholic hepatisis)
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004871 10001624 Alcoholic hepatitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002430-36 Sponsor Protocol Number: AntibioTICS Start Date*: 2012-07-02
    Sponsor Name:AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    Full Title: Multicentre, randomised, double-blinded, placebo-controlled trial of efficacy of amoxicilline/clavulanic acid in patients affected by tic disorder colonized by GAS. No-proft stidy.
    Medical condition: Chronic tic disorder
    Disease: Version SOC Term Classification Code Term Level
    14.1 10037175 - Psychiatric disorders 10043834 Tic disorder, unspecified LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing) ES (Ongoing) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002340-14 Sponsor Protocol Number: REMAP-CAP Start Date*: 2015-09-16
    Sponsor Name:University Medical Center Utrecht
    Full Title: Randomized, Embedded, Multifactorial, Adaptive Platform trial for Community-Acquired Pneumonia (REMAP-CAP). (COVID-19)
    Medical condition: Severe Community Acquired Pneumonia COVID-19
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10010120 Community acquired pneumonia LLT
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) IE (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Completed) BE (Trial now transitioned) DE (Ongoing) HR (Trial now transitioned) ES (Temporarily Halted) FR (Trial now transitioned) FI (Ongoing) IT (Trial now transitioned) CZ (Trial now transitioned) SI (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-022518-16 Sponsor Protocol Number: KADFUT Start Date*: 2011-07-13
    Sponsor Name:King's College Hospital NHS Foundation Trust
    Full Title: A prospective single blind randomised controlled study to compare the outcomes of patients with diabetes and clinically non-infected ischaemic and neuropathic foot ulcers treated with and without ...
    Medical condition: foot ulcers with no clinical signs of infection in patients with diabetes.
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    14.0 10027433 - Metabolism and nutrition disorders 10012664 Diabetic foot ulcer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004298-24 Sponsor Protocol Number: KCH-STR-INF Start Date*: 2008-08-13
    Sponsor Name:King's College Hospital NHS Foundation Trust [...]
    1. King's College Hospital NHS Foundation Trust
    2. King's College London
    Full Title: A cluster randomised trial of different strategies of antibiotic use to reduce the incidence and consequences of chest infection in acute stroke patients with swallowing problems.
    Medical condition: Acute stroke patients with dysphagia and at high risk of aspiration as assessed by the bedside swallowing assessment. A policy to prevent pneumonias with prophylactic antibiotics is being investig...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029205 - Nervous system disorders 10052081 Complication of acute stroke LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002366-40 Sponsor Protocol Number: 13.0095 Start Date*: 2013-07-19
    Sponsor Name:St George’s, University of London
    Full Title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials study
    Medical condition: The study is not restricted to any specific condition. The study population will include children (aged under 16 years) admitted to hospital and routinely prescribed one of the study penicillins ac...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2014-000202-35 Sponsor Protocol Number: I13018 Start Date*: 2015-01-30
    Sponsor Name:CHU de LIMOGES
    Full Title: Prevention of early ventilator-associated pneumonia with antibiotic therapy in patients treated with mild therapeutic hypothermia after cardiac arrest. Randomized, multicenter double-blind placeb...
    Medical condition: Pneumonia
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10047263 Ventilation pneumonitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-000864-28 Sponsor Protocol Number: DAP-PEDOST-11-03 Start Date*: 2014-01-02
    Sponsor Name:Cubist Pharmaceuticals, LLC
    Full Title: A Multicenter, Randomized, Double-Blinded Comparative Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Daptomycin Versus Active Comparator in Pediatric Subjects With Acute Hematogeno...
    Medical condition: Acute Hematogenous Osteomyelitis Due to Gram-Positive Organisms
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10009081 Chronic osteomyelitis LLT
    19.1 100000004862 10046076 Unspecified osteomyelitis LLT
    19.1 100000004862 10009091 Chronic osteomyelitis, site unspecified LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) IT (Completed) ES (Completed) GR (Completed) LV (Completed) GB (Completed) EE (Completed) BG (Completed) FR (Completed) SI (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003176-36 Sponsor Protocol Number: Duration Start Date*: 2011-12-20
    Sponsor Name:FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO
    Full Title: Individualizing duration of antibiotic therapy in hospitalized patients with community-acquired pneumonia: a non-inferiority, randomized, controlled trial.
    Medical condition: Subjects with diagnosis of pneumonia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10035739 Pneumonia, organism unspecified LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012963-33 Sponsor Protocol Number: CORTEEC Start Date*: 2010-10-04
    Sponsor Name:ALFREDO TAGARRO GARCIA
    Full Title: ENSAYO CLINICO FASE II CORTICOIDES PARA EL EMPIEMA Y EL DERRAME PLEURAL PARANEUMÓNICO EN NIÑOS MULTICENTRIC, PHASE II, CLINICAL TRIAL CORTICOIDS FOR EMPYEMA AND PLEURAL EFFUSION IN CHILDREN
    Medical condition: DERRAME PLEURAL PARANEUMONICO (PARAPNEUMONIC PLEURAL EFFUSSION)
    Disease: Version SOC Term Classification Code Term Level
    11 10032736 Otras formas especificadas de derrame pleural, excepto el tuberculoso LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted)
    Trial results: (No results available)
    EudraCT Number: 2013-002822-21 Sponsor Protocol Number: ARCHIE001 Start Date*: 2013-10-10
    Sponsor Name:University of Oxford
    Full Title: The early use of Antibiotics for at Risk CHildren with InfluEnza in primary care (ARCHIE): a double-blind randomised placebo-controlled trial
    Medical condition: Influenza or influenza-like illness
    Disease: Version SOC Term Classification Code Term Level
    16.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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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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