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

November 26, 2008
November 20, 2012
August 2009
October 2011   (final data collection date for primary outcome measure)
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).
Global response (defined as both clinical and microbiologic success) at the end of intravenous therapy in the modified intent to treat (MITT) group [ Time Frame: At end of intravenous treatment (Day 10 - 42) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00806351 on ClinicalTrials.gov Archive Site
  • 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
  • Response (based on clinical cure and microbiologic success) at the end of intravenous treatment, end of treatment, and 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At end of treatment (Day 14 - 56) and at the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Clinical response at Day 10 of treatment [ Time Frame: At Day 10 of treatment ] [ Designated as safety issue: No ]
  • Rates of relapse at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Rates of new infection with an organism not identified at baseline at the 2-week and 6-week follow-up visits [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Global response at end of treatment, and at the 2-week and 6-week follow-up visits in the MITT group [ Time Frame: At the 2-week and 6-week follow-up visit ] [ Designated as safety issue: No ]
  • Time to negative blood culture (if the subject had a positive blood culture at baseline) [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
  • Time to death [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: Yes ]
  • All cause mortality during the study therapy and at follow visits [ Time Frame: During and at end of study (Day 0 - 98) ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida Infection

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Fungemia
  • Neutropenia
  • Candidiasis
  • Drug: Active Anidulafungin
    Subjects in this arm will receive active anidulafungin and placebo caspofungin
  • Drug: Active Caspofungin
    Subjects in this arm will receive active caspofungin and placebo anidulafungin
  • Experimental: Anidulafungin Arm
    Subjects were randomized 2:1 (anidulafungin:caspofunin).
    Intervention: Drug: Active Anidulafungin
  • Experimental: Caspofungin Arm
    Subjects were randomized 2:1 (anidulafungin:caspofunin).
    Intervention: Drug: Active Caspofungin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
October 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina,   France,   Italy,   Poland,   Russian Federation,   Slovakia
 
NCT00806351
A8851021
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP