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

Phase 3TerminatedNCT00806351

Pfizer21 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fungemia Neutropenia Candidiasis

Interventions

Active AnidulafunginDRUG

Subjects in this arm will receive active anidulafungin and placebo caspofungin

Active CaspofunginDRUG

Subjects in this arm will receive active caspofungin and placebo anidulafungin

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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.

Locations (10)

Pfizer Investigational Site

Sarajevo, Bosnia and Herzegovina

Pfizer Investigational Site

Grenoble, France

Pfizer Investigational Site

Strasbourg, France

Pfizer Investigational Site

Bologna, Italy

Outcomes

Primary Outcomes

Global Response at End of Intravenous Treatment (EOIVT)

Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).

Time frame: Day 10 up to Day 42

Secondary Outcomes

Global Response at End of Treatment (EOT)

Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).

Time frame: Day 14 up to Day 56

Global Response at 2-Week Follow-Up Visit

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Roma, Italy

Pfizer Investigational Site

Gdansk, Poland

Pfizer Investigational Site

Warsaw, Poland

Pfizer Investigational Site

Wroclaw, Poland

Pfizer Investigational Site

Moscow, Russia

Pfizer Investigational Site

Košice, Slovakia

Time frame: 2 weeks post treatment

Global Response at 6-Week Follow-Up Visit

Time frame: 6 weeks post treatment

Response Based on Clinical Cure and Microbiological Success at EOIVT

Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).

Time frame: Day 10 up to Day 42

Response Based on Clinical Cure and Microbiological Success at EOT

Time frame: Day 14 up to Day 56

Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit

Time frame: 2 weeks post treatment

Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit

Time frame: 6 weeks post treatment

Clinical Response at Day 10

Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.

Time frame: Day 10

Number of Participants With Recurrence

Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.

Time frame: 2 and 6 weeks post treatment

Number of Participants With New Infections

Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.

Time frame: 2 and 6 weeks post treatment

Time to First Negative Blood Culture for Candida Species

A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.

Time frame: Baseline up to Day 56

Time to Death

Time to death defined as: date of death minus first treatment date plus 1.

Time frame: Day 1 up to Day 98

All-Cause Mortality

All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up

Time frame: Baseline up to 6 weeks post treatment