Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to Emmanuel Roilides  1 , Fabianne Carlesse  2 , Margaret Tawadrous  3 , Heidi Leister-Tebbe  4 , Umberto Conte  4 , Susan Raber  4 , Robert Swanson  4 , Jean L Yan  4 , Jalal A Aram  4 , Flavio Queiroz-Telles  5 ; Anidulafungin A8851008 Pediatric Study Group Affiliations Expand Affiliations 1 From the Infectious Diseases Unit, 3 Department of Pediatrics, Faculty of Medicine, Aristotle University School of Health Sciences, Hippokration General Hospital, Thessaloniki, Greece. 2 Institute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil. 3 Global Product Development, Pfizer Inc, Groton, Connecticut. 4 Pfizer Inc, New York, New York. 5 Department of Public Health, Universidade Federal do Paraná, Hospital de Clinicas, Curitiba, Paraná, Brazil. PMID: 32032174 PMCID: PMC7182240 DOI: 10.1097/INF.0000000000002568 Free PMC article Item in Clipboard

Emmanuel Roilides, Fabianne Carlesse, Margaret Tawadrous, Heidi Leister-Tebbe, Umberto Conte, Susan Raber, Robert Swanson, Jean L Yan, Jalal A Aram, Flavio Queiroz-Telles, Anidulafungin A8851008 Pediatric Study Group, Emmanuel Roilides, Fabianne Carlesse, Margaret Tawadrous, Heidi Leister-Tebbe, Umberto Conte, Susan Raber, Robert Swanson, Jean L Yan, Jalal A Aram, Flavio Queiroz-Telles, Anidulafungin A8851008 Pediatric Study Group

Abstract

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.

Conflict of interest statement

E.R. has received research grants from Astellas, Gilead, Merck, Pfizer Inc and Sanofi; and is a scientific advisor and member of speaker bureaus for Astellas, Gilead, Merck, GlaxoSmithKline, Pfizer Inc and VIANEX. F.C. has received grants from Astellas, MSD, Pfizer Inc, TEVA and United Medical. M.T., H.L.-T., U.C., S.R., J.L.Y. and J.A.A. are employees and shareholders of Pfizer Inc. R.S. is contracted by, and is a shareholder of, Pfizer Inc. F.Q.-T. has received grants from Astellas, Gilead, Merck, Pfizer Inc, TEVA and United Medical.

Figures

FIGURE 1.
FIGURE 1.
Study design.

References

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Source: PubMed

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