Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
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|ClinicalTrials.gov Identifier: NCT00761267|
Recruitment Status : Completed
First Posted : September 29, 2008
Last Update Posted : May 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Candidemia||Drug: Anidulafungin Drug: Fluconazole||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||February 27, 2009|
|Actual Primary Completion Date :||February 14, 2018|
|Actual Study Completion Date :||February 14, 2018|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00761267
Show 45 Study Locations
|Study Director:||Pfizer CT.gov Call Center||Pfizer|