PandemieGrippaleV1, PubMed, Curation, bibRecord, 001078

Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.

Identifieur interne : 001078 ( PubMed/Curation ); précédent : 001077; suivant : 001079

Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.

Auteurs : Jaime E. Hernandez [États-Unis] ; Raghavendra Adiga ; Robert Armstrong ; Jose Bazan ; Hector Bonilla ; John Bradley ; Robin Dretler ; Michael G. Ison ; Julie E. Mangino ; Stacene Maroushek ; Avinash K. Shetty ; Anna Wald ; Christine Ziebold ; Jenna Elder ; Alan S. Hollister ; William Sheridan

Source :

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [ 1537-6591 ] ; 2011.

RBID : pubmed:21367722

Descripteurs français

KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Antiviraux (administration et posologie), Antiviraux (effets indésirables), Cyclopentanes (administration et posologie), Cyclopentanes (effets indésirables), Enfant, Enfant d'âge préscolaire, Femelle, Grippe humaine (mortalité), Grippe humaine (traitement médicamenteux), Grippe humaine (virologie), Grossesse, Guanidines (administration et posologie), Guanidines (effets indésirables), Humains, Jeune adulte, Maladie grave, Mâle, Médicaments en essais cliniques (administration et posologie), Médicaments en essais cliniques (effets indésirables), Nourrisson, Résultat thérapeutique, Sous-type H1N1 du virus de la grippe A (isolement et purification), Sujet âgé, États-Unis d'Amérique.
MESH :
- administration et posologie : Antiviraux, Cyclopentanes, Guanidines, Médicaments en essais cliniques.
- effets indésirables : Antiviraux, Cyclopentanes, Guanidines, Médicaments en essais cliniques.
- isolement et purification : Sous-type H1N1 du virus de la grippe A.
- mortalité : Grippe humaine.
- traitement médicamenteux : Grippe humaine.
- virologie : Grippe humaine.
- Adolescent, Adulte, Adulte d'âge moyen, Analyse de survie, Enfant, Enfant d'âge préscolaire, Femelle, Grossesse, Humains, Jeune adulte, Maladie grave, Mâle, Nourrisson, Résultat thérapeutique, Sujet âgé, États-Unis d'Amérique.
Wicri :
- geographic : États-Unis.

English descriptors

KwdEn :
- Adolescent, Adult, Aged, Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Child, Child, Preschool, Critical Illness, Cyclopentanes (administration & dosage), Cyclopentanes (adverse effects), Drugs, Investigational (administration & dosage), Drugs, Investigational (adverse effects), Female, Guanidines (administration & dosage), Guanidines (adverse effects), Humans, Infant, Influenza A Virus, H1N1 Subtype (isolation & purification), Influenza, Human (drug therapy), Influenza, Human (mortality), Influenza, Human (virology), Male, Middle Aged, Pregnancy, Survival Analysis, Treatment Outcome, United States, Young Adult.
MESH :
- chemical , administration & dosage : Antiviral Agents, Cyclopentanes, Drugs, Investigational, Guanidines.
- chemical , adverse effects : Antiviral Agents, Cyclopentanes, Drugs, Investigational, Guanidines.
- geographic : United States.
- drug therapy : Influenza, Human.
- isolation & purification : Influenza A Virus, H1N1 Subtype.
- mortality : Influenza, Human.
- virology : Influenza, Human.
- Adolescent, Adult, Aged, Child, Child, Preschool, Critical Illness, Female, Humans, Infant, Male, Middle Aged, Pregnancy, Survival Analysis, Treatment Outcome, Young Adult.

Abstract

Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND.

DOI: 10.1093/cid/cir001
PubMed: 21367722

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Le document en format XML

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<front><div type="abstract" xml:lang="en">Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND.</div>
</front>
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<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">21367722</PMID>
<DateCompleted><Year>2011</Year>
<Month>06</Month>
<Day>07</Day>
</DateCompleted>
<DateRevised><Year>2018</Year>
<Month>11</Month>
<Day>13</Day>
</DateRevised>
<Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1537-6591</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>52</Volume>
<Issue>6</Issue>
<PubDate><Year>2011</Year>
<Month>Mar</Month>
<Day>15</Day>
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<Title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</Title>
<ISOAbbreviation>Clin. Infect. Dis.</ISOAbbreviation>
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<ArticleTitle>Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.</ArticleTitle>
<Pagination><MedlinePgn>695-706</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1093/cid/cir001</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Peramivir, an investigational intravenous neuraminidase inhibitor in Phase 3 trials for hospitalized patients, was made available during the 2009 H1N1 influenza pandemic under the Emergency Investigational New Drug (eIND) regulations. We describe the clinical characteristics and outcomes of all patients for whom peramivir was requested under the eIND.</AbstractText>
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<AbstractText Label="RESULTS" NlmCategory="RESULTS">From April through October 2009, peramivir was requested for 42 patients and administered to 20 adults and 11 children. At hospitalization, all patients had rapidly progressing, radiographically confirmed viral pneumonia with respiratory failure, and all but 1 patient required mechanical ventilation. In most patients, including 1 person with documented oseltamivir-resistant infection, the illness had progressed despite oseltamivir treatment. Peramivir was administered for 1-14 days (median duration, 10 days). The 14-day, 28-day, and 56-day survival rates were 76.7%, 66.7%, and 59.0%, respectively. Peramivir was generally well tolerated.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Intravenous peramivir was well tolerated and was associated with recovery in most patients hospitalized with severe 2009 H1N1 influenza viral pneumonia and treated under an eIND.</AbstractText>
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<ForeName>Jaime E</ForeName>
<Initials>JE</Initials>
<AffiliationInfo><Affiliation>ID Clinical Development, Clinical Pharmacology, and Clinical Development, BioCryst Pharmaceuticals, Durham, NC, USA. jhernandez@biocryst.com</Affiliation>
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<Initials>R</Initials>
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<Author ValidYN="Y"><LastName>Ison</LastName>
<ForeName>Michael G</ForeName>
<Initials>MG</Initials>
</Author>
<Author ValidYN="Y"><LastName>Mangino</LastName>
<ForeName>Julie E</ForeName>
<Initials>JE</Initials>
</Author>
<Author ValidYN="Y"><LastName>Maroushek</LastName>
<ForeName>Stacene</ForeName>
<Initials>S</Initials>
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<Author ValidYN="Y"><LastName>Shetty</LastName>
<ForeName>Avinash K</ForeName>
<Initials>AK</Initials>
</Author>
<Author ValidYN="Y"><LastName>Wald</LastName>
<ForeName>Anna</ForeName>
<Initials>A</Initials>
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<Author ValidYN="Y"><LastName>Ziebold</LastName>
<ForeName>Christine</ForeName>
<Initials>C</Initials>
</Author>
<Author ValidYN="Y"><LastName>Elder</LastName>
<ForeName>Jenna</ForeName>
<Initials>J</Initials>
</Author>
<Author ValidYN="Y"><LastName>Hollister</LastName>
<ForeName>Alan S</ForeName>
<Initials>AS</Initials>
</Author>
<Author ValidYN="Y"><LastName>Sheridan</LastName>
<ForeName>William</ForeName>
<Initials>W</Initials>
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<Author ValidYN="Y"><CollectiveName>eIND Peramivir Investigators</CollectiveName>
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<Language>eng</Language>
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<MedlineTA>Clin Infect Dis</MedlineTA>
<NlmUniqueID>9203213</NlmUniqueID>
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<NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance>
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<CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Clin Infect Dis. 2011 Mar 15;52(6):707-9</RefSource>
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<CommentsCorrections RefType="CommentIn"><RefSource>Clin Infect Dis. 2013 Jan;56(1):164</RefSource>
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<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
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Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.

Clinical experience in adults and children treated with intravenous peramivir for 2009 influenza A (H1N1) under an Emergency IND program in the United States.

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