Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Verified March 2017 by Pfizer
Information provided by (Responsible Party):
First received: September 25, 2008
Last updated: March 6, 2017
Last verified: March 2017
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).
||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
||A Prospective, Open-label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia
Primary Outcome Measures:
- To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia. [ Time Frame: Duration of the trial ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment:
| 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: Eraxis
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
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). To participate in the study, at the time of enrollment subjects must (1) have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp or (2) in infants 1 month to < 2 years only, be at high risk of candidiasis. All subjects meeting screening criteria receive IV anidulafungin. Subjects will be stratified by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years). Subjects may be switched to oral fluconazole, provided that the pre-specified criteria are met. Subjects with microbiologically confirmed ICC must have a minimum total treatment duration of 14 days. The maximum allowed treatment duration of anidulafungin is 35 days; the maximum total treatment duration for the study is 49 days. At selected centers, anidulafungin pharmacokinetics will be assessed in the first 6 subjects age 1 month - < 2 years to confirm the recommended dosage regimen. A population PK-PD analysis will be performed in all other enrolled subjects. Subjects will be followed for safety through 6 week FU visit. Efficacy for subjects with confirmed ICC will be assessed at EOIVT, EOT, 2-week FU and 6-week FU visits.
|Ages Eligible for Study:
||1 Month to 17 Years (Child)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)
- Male and female patients from 1 month to less than 18 years of age.
- Any patients with allergy to the drug; and any pregnant female or lactating.
- Failed previous antifungal therapy or expected to live < 3 days.
- Patients with documented or suspected Candida meningitis.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761267
|Contact: Pfizer CT.gov Call Center
||Pfizer CT.gov Call Center
History of Changes
|Other Study ID Numbers:
2008-004150-32 ( EudraCT Number )
|Study First Received:
||September 25, 2008
||March 6, 2017
|Individual Participant Data
|Plan to Share IPD:
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 24, 2017
Systemic Inflammatory Response Syndrome
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors