Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Prospective, Open-label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia|
- To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia. [ Time Frame: Duration of the trial ]
- To assess rates of relapse at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
- To assess all-cause mortality during study therapy and follow-up visits [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ]
- To explore pharmacokinetic parameters of anidulafungin in children aged 1 month to <2 years following IV infusion of anidulafungin (area under curve over dosing interval (AUC24) and peak concentration (Cmax)); [ Time Frame: Day 1 - Day 2 ]
- To assess the efficacy of anidulafungin, as measured by global response, at the following time points: EOIVT, EOT, 2-week FU visit and 6-week FU visit [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ]
- To explore the exposure-response (safety and efficacy endpoints) relationship of anidulafungin using a nonlinear mixed effects approach as appropriate, including exploring the association between PK-PD index (eg, AUC/MIC) and efficacy endpoints; [ Time Frame: Day 1 - Day 9, at specified collection time points ]
- To assess rates of new infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ]
- • To explore pharmacokinetic parameters of polysorbate 80 following IV infusion of anidulafungin (AUC24 and Cmax) [ Time Frame: Day 1 - Day 9, at specified collection times ]
|Actual Study Start Date:||February 27, 2009|
|Estimated Study Completion Date:||June 12, 2019|
|Estimated Primary Completion Date:||June 12, 2019 (Final data collection date for primary outcome measure)|
Experimental: Anidulafungin IV
All subjects meeting screening criteria will receive IV anidulafungin.
Day 1: loading dose of 3 mg/kg (not to exceed 200 mg) Day 2 onwards: maintain a dose of 1.5 mg/kg (not to exceed 100 mg). Minimum total treatment duration is 14 days. Minimum IV anidulafungin treatment duration is 10 days for subjects with microbiologically confirmed ICC and 5 days for subjects at risk of candidiasis; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day).
Maximum treatment duration with anidulafungin is 35 days.
Other Name: EraxisDrug: Fluconazole
Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria. Maximum total treatment duration is 49 days.
Other Name: Diflucan
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761267
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|