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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00761267
First received: September 25, 2008
Last updated: July 24, 2014
Last verified: July 2014

September 25, 2008
July 24, 2014
February 2009
June 2016   (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 at the EOIVT and EOT time points [ Time Frame: EOIVT and EOT ] [ 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: 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 ]
  • 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 ]
Not Provided
Not Provided
 
Study To Assess The Safety, Pharmacokinetics, And Evaluate The Response To 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 Candidaemia

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

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
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. 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
Experimental: 1
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 2016
June 2016   (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
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   Brazil,   Canada,   Greece,   Italy,   Korea, Republic of,   Portugal,   Russian Federation,   Spain,   Taiwan
 
NCT00761267
A8851008
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2014

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