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

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00761267

Purpose

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

Condition	Intervention	Phase
Candidemia Candidiasis	Drug: anidulafungin Drug: fluconazole	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective, Open-Label Study To Assess The Pharmacokinetics, Safety & Efficacy Of Anidulafungin When Used To Treat Children With Invasive Candidiasis, Including Candidaemia

Resource links provided by NLM:

MedlinePlus related topics: Yeast Infections

Drug Information available for: Fluconazole Anidulafungin

U.S. FDA Resources

Further study details as provided by Pfizer:

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 ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]

Estimated Enrollment:	60
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	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: a minimum IV anidulafungin treatment of 10 days, and study specific clinical improvement criteria are met. Other Name: Diflucan

Arms

Assigned Interventions

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.

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:

a minimum IV anidulafungin treatment of 10 days, and
study specific clinical improvement criteria are met.

Other Name: Diflucan

Eligibility

Ages Eligible for Study:	1 Month to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00761267

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 41 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00761267 History of Changes
Other Study ID Numbers:	A8851008
Study First Received:	September 25, 2008
Last Updated:	January 19, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Anidulafungin
pediatrics
candidemia
invasive candidiasis
safety

Additional relevant MeSH terms:

Candidiasis
Candidemia
Candidiasis, Invasive
Mycoses
Fungemia
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

Fluconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012