drugset / Trial / NCT00761267
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
NaSingle-groupOpen-labelTreatment
Summary
Prospective, open label study to assess the pharmacokinetics, safety \& efficacy of anidulafungin when used to treat children (aged 1 month - \<18 years) with invasive candidiasis, including candidemia (ICC).
Timeline
- Start
- 2009-02
- Primary completion
- 2018-02
- Completion
- 2018-02
Publications
- Roilides E, Carlesse F, Tawadrous M, Leister-Tebbe H, Conte U, Raber S, Swanson R, Yan JL, Aram JA, Queiroz-Telles F; Anidulafungin A8851008 Pediatric Study Group. Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age With Invasive Candidiasis, Including Candidemia. Pediatr Infect Dis J. 2020 Apr;39(4):305-309. doi: 10.1097/INF.0000000000002568.
- Roilides E, Carlesse F, Leister-Tebbe H, Conte U, Yan JL, Liu P, Tawadrous M, Aram JA, Queiroz-Telles F; Anidulafungin A8851008 Pediatric Study Group. A Prospective, Open-label Study to Assess the Safety, Tolerability and Efficacy of Anidulafungin in the Treatment of Invasive Candidiasis in Children 2 to <18 Years of Age. Pediatr Infect Dis J. 2019 Mar;38(3):275-279. doi: 10.1097/INF.0000000000002237.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Anidulafungin | Other / unclassified | 1.5 mg/kg | Intravenous |
| Background | Fluconazole | Small molecule | 6 mg/kg | Oral |
| Background | Fluconazole | Small molecule | 12 mg/kg | Oral |