Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis


Tracking Information

Start Date  ICMJENovember 2008
Estimated Primary Completion DateJanuary 2012   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 8, 2008)		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 ]
Original Primary Outcome Measures  ICMJE 
 (submitted: September 26, 2008)		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 ]
Change HistoryComplete list of historical versions of study NCT00761267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: September 26, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEStudy To Assess The Safety, Pharmacokinetics, And Evaluate The Response To Anidulafungin When Treating Children With Invasive Candidiasis
Official Title  ICMJEA Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidaemia
Brief Summary

Anidulafungin (an antifungal drug) is relatively safe and the benefits outweigh the adverse effects when used in children diagnosed with invasive candidiasis, including candidemia.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Condition  ICMJE
  • Candidemia
  • Candidiasis
Intervention  ICMJE
  • 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. Maximum follow up duration is 6 weeks after the end of treatment.

    Other Name: Eraxis
  • Drug: fluconazole

    Minimum IV anidulafungin treatment duration is 10 days; followed by oral fluconazole 6-12 mg/kg/day (not to exceed 800mg/day). Switch of treatment to fluconazole may only occur after:

    1. a minimum IV anidulafungin treatment of 10 days, and
    2. study specific clinical improvement criteria are met.
    Other Name: Diflucan
Study Arms / Comparison Groups1: Experimental
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

Recruitment Information

Estimated Enrollment  ICMJE80
Estimated Completion DateJanuary 2012
Estimated Primary Completion DateJanuary 2012   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 suspected Candida osteomyelitis, endocarditis or meningitis.
GenderBoth
Ages1 Month to 17 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021
Location Countries  ICMJEUnited States,   Canada,   France,   Greece,   Italy,   Korea, Republic of,   Portugal,   Russian Federation,   Spain,   Taiwan

Administrative Information

NCT ID  ICMJENCT00761267
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer Inc.
Study ID Numbers  ICMJEA8851008
Study Sponsor  ICMJEPfizer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
Information Provided ByPfizer