AustralieFrV1, PubMed, Curation, bibRecord, 001922

A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

Identifieur interne : 001922 ( PubMed/Curation ); précédent : 001921; suivant : 001923

A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

Auteurs : James S. Mccarthy [Australie] ; Thomas Rückle [Suisse] ; Elhadj Djeriou [France] ; Cathy Cantalloube [France] ; Daniel Ter-Minassian [France] ; Mark Baker [Suisse] ; Peter O'Rourke [Australie] ; Paul Griffin [Australie] ; Louise Marquart [Australie] ; Rob Hooft Van Huijsduijnen [Suisse] ; Jörg J. Möhrle [Suisse]

Source :

Malaria journal [ 1475-2875 ] ; 2016.

RBID : pubmed:27624471

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Aminoquinoléines (administration et posologie), Aminoquinoléines (pharmacocinétique), Aminoquinoléines (pharmacologie), Analyse chimique du sang, Antipaludiques (administration et posologie), Antipaludiques (pharmacocinétique), Antipaludiques (pharmacologie), Charge parasitaire, Chromatographie en phase liquide, Composés du fer II (administration et posologie), Composés du fer II (pharmacocinétique), Composés du fer II (pharmacologie), Femelle, Humains, Jeune adulte, Mâle, Paludisme à Plasmodium falciparum (traitement médicamenteux), Plasmodium falciparum (), Plasmodium falciparum (isolement et purification), Réaction de polymérisation en chaine en temps réel, Résultat thérapeutique, Sang (parasitologie), Spectrométrie de masse en tandem, Volontaires sains.
MESH :
- administration et posologie : Aminoquinoléines, Antipaludiques, Composés du fer II.
- isolement et purification : Plasmodium falciparum.
- parasitologie : Sang.
- pharmacocinétique : Aminoquinoléines, Antipaludiques, Composés du fer II.
- pharmacologie : Aminoquinoléines, Antipaludiques, Composés du fer II.
- traitement médicamenteux : Paludisme à Plasmodium falciparum.
- Adolescent, Adulte, Adulte d'âge moyen, Analyse chimique du sang, Charge parasitaire, Chromatographie en phase liquide, Femelle, Humains, Jeune adulte, Mâle, Plasmodium falciparum, Réaction de polymérisation en chaine en temps réel, Résultat thérapeutique, Spectrométrie de masse en tandem, Volontaires sains.

English descriptors

KwdEn :
- Adolescent, Adult, Aminoquinolines (administration & dosage), Aminoquinolines (pharmacokinetics), Aminoquinolines (pharmacology), Antimalarials (administration & dosage), Antimalarials (pharmacokinetics), Antimalarials (pharmacology), Blood (parasitology), Blood Chemical Analysis, Chromatography, Liquid, Female, Ferrous Compounds (administration & dosage), Ferrous Compounds (pharmacokinetics), Ferrous Compounds (pharmacology), Healthy Volunteers, Humans, Malaria, Falciparum (drug therapy), Male, Middle Aged, Parasite Load, Plasmodium falciparum (drug effects), Plasmodium falciparum (isolation & purification), Real-Time Polymerase Chain Reaction, Tandem Mass Spectrometry, Treatment Outcome, Young Adult.
MESH :
- chemical , administration & dosage : Aminoquinolines, Antimalarials, Ferrous Compounds.
- chemical , pharmacokinetics : Aminoquinolines, Antimalarials, Ferrous Compounds.
- chemical , pharmacology : Aminoquinolines, Antimalarials, Ferrous Compounds.
- drug effects : Plasmodium falciparum.
- drug therapy : Malaria, Falciparum.
- isolation & purification : Plasmodium falciparum.
- parasitology : Blood.
- Adolescent, Adult, Blood Chemical Analysis, Chromatography, Liquid, Female, Healthy Volunteers, Humans, Male, Middle Aged, Parasite Load, Real-Time Polymerase Chain Reaction, Tandem Mass Spectrometry, Treatment Outcome, Young Adult.

Abstract

Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers.

DOI: 10.1186/s12936-016-1511-3
PubMed: 27624471

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<term>Adult</term>
<term>Aminoquinolines (administration & dosage)</term>
<term>Aminoquinolines (pharmacokinetics)</term>
<term>Aminoquinolines (pharmacology)</term>
<term>Antimalarials (administration & dosage)</term>
<term>Antimalarials (pharmacokinetics)</term>
<term>Antimalarials (pharmacology)</term>
<term>Blood (parasitology)</term>
<term>Blood Chemical Analysis</term>
<term>Chromatography, Liquid</term>
<term>Female</term>
<term>Ferrous Compounds (administration & dosage)</term>
<term>Ferrous Compounds (pharmacokinetics)</term>
<term>Ferrous Compounds (pharmacology)</term>
<term>Healthy Volunteers</term>
<term>Humans</term>
<term>Malaria, Falciparum (drug therapy)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parasite Load</term>
<term>Plasmodium falciparum (drug effects)</term>
<term>Plasmodium falciparum (isolation & purification)</term>
<term>Real-Time Polymerase Chain Reaction</term>
<term>Tandem Mass Spectrometry</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
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<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Aminoquinoléines (administration et posologie)</term>
<term>Aminoquinoléines (pharmacocinétique)</term>
<term>Aminoquinoléines (pharmacologie)</term>
<term>Analyse chimique du sang</term>
<term>Antipaludiques (administration et posologie)</term>
<term>Antipaludiques (pharmacocinétique)</term>
<term>Antipaludiques (pharmacologie)</term>
<term>Charge parasitaire</term>
<term>Chromatographie en phase liquide</term>
<term>Composés du fer II (administration et posologie)</term>
<term>Composés du fer II (pharmacocinétique)</term>
<term>Composés du fer II (pharmacologie)</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Paludisme à Plasmodium falciparum (traitement médicamenteux)</term>
<term>Plasmodium falciparum ()</term>
<term>Plasmodium falciparum (isolement et purification)</term>
<term>Réaction de polymérisation en chaine en temps réel</term>
<term>Résultat thérapeutique</term>
<term>Sang (parasitologie)</term>
<term>Spectrométrie de masse en tandem</term>
<term>Volontaires sains</term>
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<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Aminoquinolines</term>
<term>Antimalarials</term>
<term>Ferrous Compounds</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacokinetics" xml:lang="en"><term>Aminoquinolines</term>
<term>Antimalarials</term>
<term>Ferrous Compounds</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="pharmacology" xml:lang="en"><term>Aminoquinolines</term>
<term>Antimalarials</term>
<term>Ferrous Compounds</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Aminoquinoléines</term>
<term>Antipaludiques</term>
<term>Composés du fer II</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Plasmodium falciparum</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Malaria, Falciparum</term>
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<keywords scheme="MESH" qualifier="isolement et purification" xml:lang="fr"><term>Plasmodium falciparum</term>
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<keywords scheme="MESH" qualifier="pharmacocinétique" xml:lang="fr"><term>Aminoquinoléines</term>
<term>Antipaludiques</term>
<term>Composés du fer II</term>
</keywords>
<keywords scheme="MESH" qualifier="pharmacologie" xml:lang="fr"><term>Aminoquinoléines</term>
<term>Antipaludiques</term>
<term>Composés du fer II</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Paludisme à Plasmodium falciparum</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Blood Chemical Analysis</term>
<term>Chromatography, Liquid</term>
<term>Female</term>
<term>Healthy Volunteers</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parasite Load</term>
<term>Real-Time Polymerase Chain Reaction</term>
<term>Tandem Mass Spectrometry</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Analyse chimique du sang</term>
<term>Charge parasitaire</term>
<term>Chromatographie en phase liquide</term>
<term>Femelle</term>
<term>Humains</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Plasmodium falciparum</term>
<term>Réaction de polymérisation en chaine en temps réel</term>
<term>Résultat thérapeutique</term>
<term>Spectrométrie de masse en tandem</term>
<term>Volontaires sains</term>
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<front><div type="abstract" xml:lang="en">Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">27624471</PMID>
<DateCreated><Year>2016</Year>
<Month>09</Month>
<Day>14</Day>
</DateCreated>
<DateCompleted><Year>2017</Year>
<Month>06</Month>
<Day>06</Day>
</DateCompleted>
<DateRevised><Year>2017</Year>
<Month>11</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1475-2875</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>15</Volume>
<PubDate><Year>2016</Year>
<Month>Sep</Month>
<Day>13</Day>
</PubDate>
</JournalIssue>
<Title>Malaria journal</Title>
<ISOAbbreviation>Malar. J.</ISOAbbreviation>
</Journal>
<ArticleTitle>A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.</ArticleTitle>
<Pagination><MedlinePgn>469</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s12936-016-1511-3</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Ferroquine (SSR97193) is a candidate anti-malarial currently undergoing clinical trials for malaria. To better understand its pharmacokinetic (PK) and pharmacodynamic (PD) parameters the compound was tested in the experimentally induced blood stage malaria infection model in volunteers.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">Male and non-pregnant female aged 18-50 years were screened for this phase II, controlled, single-centre clinical trial. Subjects were inoculated with ~1800 viable Plasmodium falciparum 3D7A-infected human erythrocytes, and treated with a single-dose of 800 mg ferroquine. Blood samples were taken at defined time-points to measure PK and PD parameters. The blood concentration of ferroquine and its active metabolite, SSR97213, were measured on dry blood spot samples by ultra-performance liquid chromatography with tandem mass spectrometry (LC-MS/MS). Parasitaemia and emergence of gametocytes were monitored by quantitative PCR. Safety was determined by recording adverse events and monitoring clinical laboratory assessments during the course of the study.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">Eight subjects were enrolled into the study, inoculated with infected erythrocytes and treated with 800 mg ferroquine. Ferroquine was rapidly absorbed with maximal exposure after 4-8 and 4-12 h exposure for SSR97213. Non-compartmental PK analysis resulted in estimates for half-lives of 10.9 and 23.8 days for ferroquine and SSR97213, respectively. Parasite clearance as reported by parasite reduction ratio was 162.9 (95 % CI 141-188) corresponding to a parasite clearance half-life of 6.5 h (95 % CI: 6.4-6.7 h). PK/PD modelling resulted in a predicted minimal parasiticidal concentration of 20 ng/mL, and the single dosing tested in this study was predicted to maintain an exposure above this threshold for 454 h (37.8 days). Although ferroquine was overall well tolerated, transient elevated transaminase levels were observed in three subjects. Paracetamol was the only concomitant treatment among the two out of these three subjects that may have played a role in the elevated transaminases levels. No clinically significant ECG abnormalities were observed.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">The parameters and PK/PD model derived from this study pave the way to the further rational development of ferroquine as an anti-malarial partner drug. The safety of ferroquine has to be further explored in controlled human trials. Trial registration anzctr.org.au (registration number: ACTRN12613001040752), registered 18/09/2013.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>McCarthy</LastName>
<ForeName>James S</ForeName>
<Initials>JS</Initials>
<AffiliationInfo><Affiliation>QIMR Berghofer Medical Research Institute, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University of Queensland, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
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<ForeName>Thomas</ForeName>
<Initials>T</Initials>
<AffiliationInfo><Affiliation>Medicines for Malaria Venture, Route de Pré-Bois 20, 1215, Meyrin, Geneva, Switzerland.</Affiliation>
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<AffiliationInfo><Affiliation>Sanofi Aventis Recherche Développement, Chilly-Mazarin, France.</Affiliation>
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<Initials>D</Initials>
<AffiliationInfo><Affiliation>Sanofi Aventis Recherche Développement, Chilly-Mazarin, France.</Affiliation>
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<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Medicines for Malaria Venture, Route de Pré-Bois 20, 1215, Meyrin, Geneva, Switzerland.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Novartis Consumer Health SA, 2 route de l'Etraz, Case Postale 1279, 1260, Nyon, Switzerland.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>O'Rourke</LastName>
<ForeName>Peter</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>QIMR Berghofer Medical Research Institute, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
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<Author ValidYN="Y"><LastName>Griffin</LastName>
<ForeName>Paul</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>QIMR Berghofer Medical Research Institute, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>University of Queensland, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Mater Health Services, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Q-Pharm Pty Ltd, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Marquart</LastName>
<ForeName>Louise</ForeName>
<Initials>L</Initials>
<AffiliationInfo><Affiliation>QIMR Berghofer Medical Research Institute, Brisbane, Australia.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Hooft van Huijsduijnen</LastName>
<ForeName>Rob</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Medicines for Malaria Venture, Route de Pré-Bois 20, 1215, Meyrin, Geneva, Switzerland.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Möhrle</LastName>
<ForeName>Jörg J</ForeName>
<Initials>JJ</Initials>
<AffiliationInfo><Affiliation>Medicines for Malaria Venture, Route de Pré-Bois 20, 1215, Meyrin, Geneva, Switzerland. moehrlej@mmv.org.</Affiliation>
</AffiliationInfo>
</Author>
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<Language>eng</Language>
<PublicationTypeList><PublicationType UI="D017427">Clinical Trial, Phase II</PublicationType>
<PublicationType UI="D016428">Journal Article</PublicationType>
<PublicationType UI="D016449">Randomized Controlled Trial</PublicationType>
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<ArticleDate DateType="Electronic"><Year>2016</Year>
<Month>09</Month>
<Day>13</Day>
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<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Malar J</MedlineTA>
<NlmUniqueID>101139802</NlmUniqueID>
<ISSNLinking>1475-2875</ISSNLinking>
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<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000634" MajorTopicYN="N">Aminoquinolines</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
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<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
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<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName>
<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D001769" MajorTopicYN="N">Blood</DescriptorName>
<QualifierName UI="Q000469" MajorTopicYN="N">parasitology</QualifierName>
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<MeshHeading><DescriptorName UI="D005296" MajorTopicYN="N">Ferrous Compounds</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000493" MajorTopicYN="N">pharmacokinetics</QualifierName>
<QualifierName UI="Q000494" MajorTopicYN="N">pharmacology</QualifierName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016778" MajorTopicYN="N">Malaria, Falciparum</DescriptorName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D059208" MajorTopicYN="N">Parasite Load</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D010963" MajorTopicYN="N">Plasmodium falciparum</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
<QualifierName UI="Q000302" MajorTopicYN="N">isolation & purification</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D060888" MajorTopicYN="N">Real-Time Polymerase Chain Reaction</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D053719" MajorTopicYN="N">Tandem Mass Spectrometry</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">Drug discovery</Keyword>
<Keyword MajorTopicYN="Y">Ferrochloroquine</Keyword>
<Keyword MajorTopicYN="Y">Ferroquine</Keyword>
<Keyword MajorTopicYN="Y">Induced blood-stage malaria (IBSM)</Keyword>
<Keyword MajorTopicYN="Y">Malaria</Keyword>
<Keyword MajorTopicYN="Y">Pharmacokinetic/pharmacodynamic modelling</Keyword>
<Keyword MajorTopicYN="Y">Plasmodium falciparum</Keyword>
<Keyword MajorTopicYN="Y">SSR97193</Keyword>
<Keyword MajorTopicYN="Y">Translational models</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year>
<Month>03</Month>
<Day>23</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2016</Year>
<Month>08</Month>
<Day>31</Day>
</PubMedPubDate>
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<Month>9</Month>
<Day>15</Day>
<Hour>6</Hour>
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<Month>9</Month>
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<PubMedPubDate PubStatus="medline"><Year>2017</Year>
<Month>6</Month>
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	Serveur d'exploration sur les relations entre la France et l'Australie
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A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

A Phase II pilot trial to evaluate safety and efficacy of ferroquine against early Plasmodium falciparum in an induced blood-stage malaria infection study.

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