Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
Verified January 2017 by Pfizer
Information provided by (Responsible Party):
First received: September 25, 2008
Last updated: January 17, 2017
Last verified: January 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).
||Masking: Open Label
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2019 (Final data collection date for primary outcome measure)
Experimental: Anidulafungin IV
All subjects meeting screening criteria will receive IV anidulafungin. Subjects with documented or highly suspected candida infection will be initiated on therapy. Subjects enrolled on the basis of high suspicion of candida infection are required to have confirmation of candida infection within 96 hours post treatment initiation. Subjects failing to confirm within this time period may be discontinued from study treatment, but will remain in the study for safety follow-up evaluations.
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; 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:
- received minimum IV anidulafungin treatment of 10 days, and
- study specific clinical improvement criteria are met. 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 have either a confirmed diagnosis of ICC or mycological evidence highly suggestive of Candida sp. All subjects meeting screening criteria receive IV anidulafungin for a minimum of 10 days. Subjects will be stratisfied by age (1 month - < 2 years; 2 years - < 5 years; 5 years - < 18 years). Subjects may be swtiched to oral fluconazole after at least 10 days of IV anidulafungin treatment, provided that the pre-specified criteria are met. Subjects 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 assessed for safety and efficacy 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:
- Male and female patients from 1 month to less than 18 years of age.
- Diagnosed with invasive candidiasis including candidemia.
- 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 prosthetic devices or heart valves suspected to be the source of infection and can not be removed.
- 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:
|Study First Received:
||September 25, 2008
||January 17, 2017
Keywords provided by Pfizer:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on January 19, 2017
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