Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00761267
First received: September 25, 2008
Last updated: July 26, 2016
Last verified: July 2016

September 25, 2008
July 26, 2016
February 2009
June 2019   (final data collection date for primary outcome measure)
To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia. [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ]
To assess the safety and tolerability of anidulafungin when used to treat children with invasive candidiasis, including candidemia [ Time Frame: Duration of the trial ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00761267 on ClinicalTrials.gov Archive Site
  • To assess rates of relapse at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • To assess all-cause mortality during study therapy and follow-up visits [ Time Frame: EOIVT, EOT, Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess rates of new infection at the Week 2 and Week 6 FU visits [ Time Frame: Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • • 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 ] [ Designated as safety issue: Yes ]
  • To assess all-cause mortality at the EOIVT and EOT time points [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
  • 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: Initial few months of the trial ] [ Designated as safety issue: No ]
  • 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: At the end of treatment and follow up visits ] [ Designated as safety issue: No ]
  • 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: Duration of the trial ] [ Designated as safety issue: No ]
  • To assess rates of emerging infection at the Week 2 and Week 6 FU visits [ Time Frame: the Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
  • To assess rates of relapse at the Week 2 and Week 6 FU visits [ Time Frame: the Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis
A Prospective, Open-label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidemia
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).
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.
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Candidemia
  • Drug: 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; 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
  • Drug: Fluconazole

    Subjects may be switched to oral fluconazole [6-12 mg/kg/day (not to exceed 800mg/day] provided they meet specified criteria:

    1. received minimum IV anidulafungin treatment of 10 days, and
    2. study specific clinical improvement criteria are met. Maximum total treatment duration is 49 days.
    Other Name: Diflucan
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.
Interventions:
  • Drug: Anidulafungin
  • Drug: Fluconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2019
June 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients from 1 month to less than 18 years of age.
  • Diagnosed with invasive candidiasis including candidemia.

Exclusion Criteria:

  • 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.
Both
1 Month to 17 Years   (Child)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Brazil,   Canada,   Greece,   Italy,   Korea, Republic of,   Russian Federation,   Spain,   Taiwan
France,   Germany,   Portugal
 
NCT00761267
A8851008, 2008-004150-32
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP