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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

This study has been terminated.
(The study was prematurely terminated on May 18, 2012 due to slow enrollment. The study was not terminate due to any safety issues or concerns.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00806351
First received: November 26, 2008
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Fungemia
Neutropenia
Candidiasis
Drug: Active Anidulafungin
Drug: Active Caspofungin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Global Response at End of Intravenous Treatment (EOIVT) [ Time Frame: Day 10 up to Day 42 ] [ Designated as safety issue: No ]
    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:
  • Global Response at End of Treatment (EOT) [ Time Frame: Day 14 up to Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 10 up to Day 42 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 14 up to Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 and 6 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 and 6 weeks post treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline up to Day 56 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 up to Day 98 ] [ Designated as safety issue: Yes ]
    Time to death defined as: date of death minus first treatment date plus 1.

  • All-Cause Mortality [ Time Frame: Baseline up to 6 weeks post treatment ] [ Designated as safety issue: Yes ]
    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


Enrollment: 21
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anidulafungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Drug: Active Anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Experimental: Caspofungin Arm
Subjects were randomized 2:1 (anidulafungin:caspofunin).
Drug: Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00806351

Locations
Bosnia and Herzegovina
Pfizer Investigational Site
Sarajevo, Bosnia and Herzegovina, 71000
France
Pfizer Investigational Site
GRENOBLE Cedex 09, France, 38043
Pfizer Investigational Site
Strasbourg Cedex, France, 67098
Italy
Pfizer Investigational Site
Bologna, Italy, 40138
Pfizer Investigational Site
Roma, Italy, 00133
Poland
Pfizer Investigational Site
Gdansk, Poland, 80-952
Pfizer Investigational Site
Warszawa, Poland, 02-776
Pfizer Investigational Site
Wroclaw, Poland, 50-367
Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 115478
Slovakia
Pfizer Investigational Site
Kosice, Slovakia, 04190
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00806351     History of Changes
Other Study ID Numbers: A8851021
Study First Received: November 26, 2008
Results First Received: November 20, 2012
Last Updated: November 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia

Additional relevant MeSH terms:
Candidiasis
Infection
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Mycoses
Anidulafungin
Caspofungin
Echinocandins
Anti-Infective Agents
Antifungal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014