Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia.


Journal

The Pediatric infectious disease journal
ISSN: 1532-0987
Titre abrégé: Pediatr Infect Dis J
Pays: United States
ID NLM: 8701858

Informations de publication

Date de publication:
04 2020
Historique:
pubmed: 8 2 2020
medline: 10 2 2021
entrez: 8 2 2020
Statut: ppublish

Résumé

Nineteen patients 1 month to <2 years of age with (n = 16) or at high risk of (n = 3) invasive candidiasis received anidulafungin for 5-35 days (3 mg/kg day 1, 1.5 mg/kg daily thereafter) followed by optional fluconazole (NCT00761267). Most treatment-emergent adverse events were mild/moderate, and no treatment-related deaths occurred. End of intravenous therapy global response success rate was 68.8%. Pharmacokinetics were similar to adult patients.

Identifiants

pubmed: 32032174
doi: 10.1097/INF.0000000000002568
pmc: PMC7182240
pii: 00006454-202004000-00009
doi:

Substances chimiques

Antifungal Agents 0
Anidulafungin 9HLM53094I

Banques de données

ClinicalTrials.gov
['NCT00761267']

Types de publication

Clinical Trial, Phase III Journal Article Multicenter Study Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

305-309

Références

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pubmed: 19255017
J Pediatr Pharmacol Ther. 2012 Apr;17(2):189-95
pubmed: 23118673
Clin Infect Dis. 2003 Sep 1;37(5):634-43
pubmed: 12942393
J Pediatr. 2013 Oct;163(4):961-7.e3
pubmed: 23726546
Clin Pharmacol Ther. 2011 May;89(5):702-7
pubmed: 21412233
N Engl J Med. 2007 Jun 14;356(24):2472-82
pubmed: 17568028
Gut. 1993 Apr;34(4):565-6
pubmed: 8491409
Clin Infect Dis. 2005 Nov 1;41(9):1232-9
pubmed: 16206095
Pediatr Infect Dis J. 2019 Mar;38(3):275-279
pubmed: 30418357

Auteurs

Emmanuel Roilides (E)

From the Infectious Diseases Unit, 3 Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration General Hospital, Thessaloniki, Greece.

Fabianne Carlesse (F)

Institute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.

Margaret Tawadrous (M)

Global Product Development, Pfizer Inc, Groton, Connecticut.

Heidi Leister-Tebbe (H)

Pfizer Inc, New York, New York.

Umberto Conte (U)

Pfizer Inc, New York, New York.

Susan Raber (S)

Pfizer Inc, New York, New York.

Robert Swanson (R)

Pfizer Inc, New York, New York.

Jean L Yan (JL)

Pfizer Inc, New York, New York.

Jalal A Aram (JA)

Pfizer Inc, New York, New York.

Flavio Queiroz-Telles (F)

Department of Public Health, Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil.

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Classifications MeSH