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 3

Terminated

• Conditions: Fungemia; Neutropenia; Candidiasis
• Interventions: Drug: Active Anidulafungin; Drug: Active Caspofungin

• Registration Number: NCT00806351
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Study Start: 2009-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Disposition First Submitted: 2012-10-11
• Disposition First Submitted QC: 2012-10-11
• Disposition First Posted: 2012-10-24
• Status Verified: 2012-11
• Results First Submitted: 2012-11-20
• Results First Submitted QC: 2012-11-20
• Last Update Submitted: 2012-11-20
• Results First Posted: 2012-12-20
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anidulafungin Arm	Active Anidulafungin	Subjects were randomized 2:1 (anidulafungin:caspofunin).
Caspofungin Arm	Active Caspofungin	Subjects were randomized 2:1 (anidulafungin:caspofunin).

Primary Outcome Measures

Name	Time	Method
Global Response at End of Intravenous Treatment (EOIVT)	Day 10 up to Day 42	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).

Secondary Outcome Measures

Name	Time	Method
Global Response at End of Treatment (EOT)	Day 14 up to Day 56	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).
Global Response at 2-Week Follow-Up Visit	2 weeks post treatment	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).
Global Response at 6-Week Follow-Up Visit	6 weeks post treatment	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).
Response Based on Clinical Cure and Microbiological Success at EOIVT	Day 10 up to Day 42	Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Response Based on Clinical Cure and Microbiological Success at EOT	Day 14 up to Day 56	Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit	2 weeks post treatment	Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit	6 weeks post treatment	Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Clinical Response at Day 10	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.
Number of Participants With Recurrence	2 and 6 weeks post treatment	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.
Number of Participants With New Infections	2 and 6 weeks post treatment	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 to First Negative Blood Culture for Candida Species	Baseline up to Day 56	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 to Death	Day 1 up to Day 98	Time to death defined as: date of death minus first treatment date plus 1.
All-Cause Mortality	Baseline up to 6 weeks post treatment	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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇰 Kosice, Slovakia