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Clinical trials for Plasmodium falciparum

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   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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    41 result(s) found for: Plasmodium falciparum. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2020-003284-25 Sponsor Protocol Number: CKAF156A2202 Start Date*: 2021-02-18
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase 2 interventional, multicenter, randomized open-label study to determine the effective and tolerable dose of KAF156 and Lumefantrine Solid Dispersion Formulation in combination, given once d...
    Medical condition: Uncomplicated Plasmodium falciparum malaria
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10035500 Plasmodium falciparum infection PT
    21.1 10021881 - Infections and infestations 10016171 Falciparum malaria LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-005735-40 Sponsor Protocol Number: BCG-EHMI Start Date*: 2016-03-29
    Sponsor Name:Radboud university medical center
    Full Title: Safety and protective efficacy of BCG vaccination against controlled human malaria infection
    Medical condition: Plasmodium faciparum malaria prevention
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10036655 Prevention of malaria LLT
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    18.1 10021881 - Infections and infestations 10016171 Falciparum malaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001379-66 Sponsor Protocol Number: CHMI-trans1 Start Date*: 2016-04-28
    Sponsor Name:Radboud university medical center
    Full Title: Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model fo...
    Medical condition: Plasmodium falciparum malaria
    Disease: Version SOC Term Classification Code Term Level
    19.0 10022891 - Investigations 10070881 Malaria antibody test positive PT
    19.0 100000004862 10016171 Falciparum malaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004005-40 Sponsor Protocol Number: NL63552.000.17 Start Date*: 2018-02-15
    Sponsor Name:Radboud university medical center
    Full Title: Controlled Human Malaria Infection study to assess gametocytaemia and mosquito transmissibility in participants challenged with Plasmodium falciparum by sporozoite challenge to establish a model fo...
    Medical condition: Plasmodium falciparum malaria
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004848 10064864 Malaria antibody positive LLT
    20.0 100000004862 10016171 Falciparum malaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    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: 2021-003583-27 Sponsor Protocol Number: CKAF156A2203 Start Date*: 2024-10-15
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase 2 interventional, multicenter, randomized, open-label study in three age-descending cohorts to evaluate efficacy, safety and tolerability of KAF156 and Lumefantrine-SDF combination in the t...
    Medical condition: Plasmodium Falciparum Malaria
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10035500 Plasmodium falciparum infection PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005852-33 Sponsor Protocol Number: CCOA566B2306 Start Date*: 2016-04-11
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, single-arm study to evaluate the efficacy, safety and PK of artemether-lumefantrine Dispersible Tablet in the treatment of acute uncomplicated Plasmodium falciparum malaria in infant...
    Medical condition: The purpose of the study is to obtain efficacy, safety and pharmacokinetic (PK) data following treatment with artemether-lumefantrine dispersible tablet in infants < 5 kg of body weight (BW) with u...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-000322-21 Sponsor Protocol Number: TIP5 Start Date*: 2012-05-29
    Sponsor Name:Sanaria Inc.
    Full Title: Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis
    Medical condition: Controlled human malaria infection after immunization with cryopreserved Plasmodium falciparum sporozoites under chloroquine prophylaxis.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-001333-14 Sponsor Protocol Number: CCOA566B2303 Start Date*: 2012-03-09
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, investigator-blinded, multicenter, parallel group study to compare efficacy, safety and tolerability of Coartem® dispersible tablet formulation vs. Coartem® 6-dose crushed tablet in t...
    Medical condition: This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused by Plasmodium falciparum in children.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-004461-85 Sponsor Protocol Number: CCOA556B2401 Start Date*: 2016-04-06
    Sponsor Name:Novartis Pharma AG
    Full Title: A cluster randomized, single-centre, controlled, parallel,12-month prospective study and additional 12-month follow-up in Africa of malaria incidence in a community setting following systematic tre...
    Medical condition: This study assessed the impact of the systematic detection by Rapid Diagnostic Test (RDT) and treatment of asymptomatic carriers of malaria parasites (P. falciparum) with COA566 on the number of cl...
    Disease: Version SOC Term Classification Code Term Level
    18.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004163-21 Sponsor Protocol Number: A0661157 Start Date*: 2015-04-06
    Sponsor Name:Pfizer Inc
    Full Title: Phase 2/3, Open-Label, Comparative Trial Of Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated Plasmodium Falciparum Malaria In Children In Africa
    Medical condition: Malaria
    Disease: Version SOC Term Classification Code Term Level
    17.1 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000290-20 Sponsor Protocol Number: 204889 Start Date*: 2017-09-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase IIb randomized, open-label, controlled, multi-center study of the efficacy, safety and immunogenicity of GSK Biologicals’ candidate malaria vaccine RTS,S/AS01E evaluating schedules with or wi...
    Medical condition: Healthy volunteers (primary immunization against malaria disease caused by Plasmodium falciparum)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2018-004523-36 Sponsor Protocol Number: CVac-Tü3 Start Date*: 2019-04-17
    Sponsor Name:University Clinics Tübingen
    Full Title: Safety and protective efficacy of a simplified Plasmodium falciparum sporozoite Chemoprophylaxis Vaccine (PfSPZ-CVac) regimen in healthy malaria-naïve adults in Germany
    Medical condition: Immunization of healthy volunteers against P. falciparum infection
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10025487 Malaria PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    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: 2014-004906-14 Sponsor Protocol Number: A0661201 Start Date*: 2015-04-07
    Sponsor Name:Pfizer Inc
    Full Title: An Open Label, Non-Comparative Study To Evaluate Parasitological Clearance Rates and Pharmacokinetics of Azithromycin and Chloroquine Following Administration of a Fixed Dose Combination of Azithro...
    Medical condition: Asymptomatic Parasitemia
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-002255-15 Sponsor Protocol Number: ST3073-ST3074-DM-12-002 Start Date*: 2014-11-04
    Sponsor Name:Sigma-Tau Industrie Farmaceutiche Riunite S.p.A.
    Full Title: A phase II, open-label, multicentre, pharmacokinetic, pharmacodynamics and safety study of a new paediatric eurartesim dispersible formulation and crushed film coated eurartesim tablet, in infant p...
    Medical condition: Uncomplicated Plasmodium falciparum malaria
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004321-16 Sponsor Protocol Number: CCOA566A2417 Start Date*: 2017-08-31
    Sponsor Name:Novartis Pharma AG
    Full Title: A study of the effects of Coartem, Malarone and artesunate-mefloquine on auditory function in patients 12 years of age or older with acute uncomplicated P. falciparum malaria
    Medical condition: This study assessed the effects of artemether-lumefantrine on the auditory nerve pathway as assessed by Auditory Brainstem Response (ABR) and audiometric testing in acute uncomplicated Plasmodium f...
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2017-002723-16 Sponsor Protocol Number: PREMIVER Start Date*: 2018-04-20
    Sponsor Name:Universitaetsklinikum Tuebingen
    Full Title: Evaluation of the potential anti-malarial effect of ivermectin: a controlled human malaria infection trial
    Medical condition: In spite of remarkable progress over the last 15 years, malaria continues to be a major public health problem in the developing world with an estimated 214 million cases and 438.000 deaths in 2014....
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-005389-11 Sponsor Protocol Number: VAC035 Start Date*: 2009-05-07
    Sponsor Name:University of Oxford
    Full Title: A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria
    Medical condition: Plasmodium falciparum malaria
    Disease: Version SOC Term Classification Code Term Level
    8.1 10036655 Prevention of malaria LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-001539-19 Sponsor Protocol Number: 104298 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIb randomized, double-blind, controlled study of the safety, immunogenicity and proof-of-concept of RTS,S/AS02D, a candidate malaria vaccine, when incorporated into an Expanded Program on ...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria).
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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