An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Fungemia; Neutropenia; Candidiasis

Treatments: Drug: Active Caspofungin; Drug: Active Anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00806351

A8851021

Details and patient eligibility

About

The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Enrollment: 21 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dysfunctional immune system (reduced neutrophils).
• Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.
• Male of female ≥16 years of age.
• Expected hospitalization for at least ten (10) days.

Exclusion criteria

• Pregnancy or breast feeding or planning to become pregnant during the study.
• Recent treatment with one of the study drugs over the last 30 days.
• Allergy to either study drug or to this class of drugs.
• Significant liver dysfunction.
• Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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21 participants in 2 patient groups

Anidulafungin Arm

Experimental group

Description:

Subjects were randomized 2:1 (anidulafungin:caspofunin).

Treatment:

Drug: Active Anidulafungin

Caspofungin Arm

Experimental group

Description:

Subjects were randomized 2:1 (anidulafungin:caspofunin).

Treatment:

Drug: Active Caspofungin