161. Safety and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children
Session: Poster Abstract Session: Clinical Mycology
Thursday, October 5, 2017
Room: Poster Hall CD
Posters
  • IDWeek_Roilides_ePoster 161.pdf (123.3 kB)
  • Background: Treatment with an echinocandin is recommended as first-line therapy of patients with invasive candidiasis including candidemia (ICC). Little is known about the efficacy and safety of anidulafungin (ANID) for the management of ICC in children.

    Methods: Subjects aged 1 mo to 17 yrs with ICC were enrolled into a prospective, open-label, non-comparative, multi-center, global study (NCT00761267) to receive ANID (3 mg/kg on day 1, 1.5 mg/kg daily thereafter). An interim analysis was completed in children 2-17 yrs. Subjects were to receive ANID for at least 10 d up to 35 d. A central venous catheter suspected as a site of infection was to be removed. A switch to oral fluconazole could be made after day 10. Treatment was required for at least 14 d after two negative cultures separated by 24h. Efficacy, based on a determination of global response (combination of clinical and microbiological response) was assessed at End of IV Treatment (EOIVT), End of Treatment (EOT), 2- and 6-wk follow up. Safety was assessed through 6-wk follow-up.

    Results: A total of 48 subjects (18, 2-<5 yrs; 30, 5-17 yrs) received at least 1 dose of ANID (mean 11 d; range 1-35 d) and were assessed for safety. Forty-seven subjects had microbiologically confirmed ICC and were evaluated for efficacy. The most common baseline pathogens were C. albicans (38%) and C. parapsilosis (26%). Forty-four (93.6%) subjects had candidemia only. Global response success rates at EOIVT and EOT were 72.3% and 74.5%, respectively. All subjects reported at least 1 treatment emergent adverse event (AE) with diarrhoea (22.9%), vomiting (22.9%) and pyrexia (18.8%) being most frequent. Five subjects discontinued treatment due to AEs of which 4 [increased transaminases (2), vomiting, pruritus generalis] were considered related to ANID. All-cause mortality by the 2- and 6-wk follow-up visit was 12.5% and 14.6%, respectively. Of the 7 deaths during the study, 1 was considered related to ICC; 2 were related to disease progression (Ewing’s sarcoma, medulloblastoma); the remaining were related to other conditions (intracranial hemorrhage, sepsis/septic shock, respiratory failure).

    Conclusion: Anidulafungin was effective with an acceptable tolerability and safety profile in children aged 2 to 17 yrs diagnosed with ICC.

    Emmanuel Roilides, MD, PhD1, Fabianne Carlesse, MD2, Heidi Leister-Tebbe, BSN3, Umberto Conte, PharmD4, Jean Li Yan, MS5, Ping Liu, PhD6, Margaret Tawadrous, MD4, Jalal Aram, MD7 and Flavio Queiroz-Telles, MD, PhD8, (1)Infectious Diseases Unit, 3rd Department of Paediatrics, Aristotle University of Thessaloniki and Hippokration General Hospital, Thessaloniki, Greece, (2)Institute of Pediatric Oncology (GRAACC), Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil, (3)Pfizer, Inc., Collegeville, PA, (4)Pfizer Inc., New York, NY, (5)Pfizer Inc., Collegeville, PA, (6)Pfizer Inc., Beijing, China, (7)Pfizer Inc, Collegeville, PA, (8)Universidade Federal do Paraná, Hospital de Clínicas, Curitiba, Paraná, Brazil

    Disclosures:

    E. Roilides, Pfizer: Grant Investigator , Investigator , Research Contractor and Speaker's Bureau , Grant recipient , Research grant and Speaker honorarium

    F. Carlesse, None

    H. Leister-Tebbe, Pfizer: Employee , Salary

    U. Conte, Pfizer Inc: Employee , Salary

    J. L. Yan, Pfizer: Employee , Salary

    P. Liu, Pfizer: Employee , Salary

    M. Tawadrous, Pfizer: Employee , Salary

    J. Aram, Pfizer Inc: Employee , Salary

    F. Queiroz-Telles, Pfizer: Grant Investigator , Research grant

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