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:	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:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
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: 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: Week 2 and Week 6 FU visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	80
Study Start Date:	March 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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.	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. 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.

Arms

Assigned Interventions

1: 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.

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.

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.

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 suspected Candida osteomyelitis, endocarditis or 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 46 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 Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A8851008
Study First Received:	September 25, 2008
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT00761267 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Anidulafungin
pediatrics
candidemia
invasive candidiasis
safety

Additional relevant MeSH terms:

Fluconazole
Anti-Infective Agents
Mycoses
Echinocandins
Candidiasis

Therapeutic Uses
Antifungal Agents
Antibiotics, Antifungal
Pharmacologic Actions
Anidulafungin

ClinicalTrials.gov processed this record on February 08, 2010