Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis

Phase 4

Completed

• Conditions: Candidiasis
• Interventions: Drug: Eraxis (anidulafungin); Drug: Diflucan (fluconazole); Drug: Vfend (voriconazole)

• Registration Number: NCT00496197
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-05-12
• Status Verified: 2011-08
• Results First Submitted QC: 2011-08-29
• Last Update Submitted: 2011-08-29
• Results First Posted: 2011-10-03
• Last Update Posted: 2011-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 282

Inclusion Criteria

• Male or female subjects > or equal to 18 years of age.
• Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
• Subjects who received no more than one prior dose of an echinocandin or polyene.

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Exclusion Criteria

• Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
• Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
• Subjects with infected prosthetic devices which cannot be removed within 24 hours

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1.	Diflucan (fluconazole)	Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
1.	Vfend (voriconazole)	Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.
1.	Eraxis (anidulafungin)	Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)	End of Treatment (Day 5 up to Day 42)	Success: Clinical response=Cure (no signs, symptoms \[s/s\] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up \[f/u\] culture negative) or Presumed Eradication (f/u culture not available \[n/a\] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species \[spp\]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Clinical Response at EOT	End of Treatment (Day 5 up to Day 42)	Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Number of Participants With Microbiological Response at EOT	End of Treatment (Day 5 up to Day 42)	Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)	End of Intravenous treatment (Day 5 up to Day 28)	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Clinical Response at EOIV	End of Intravenous treatment (Day 5 up to Day 28)	Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Number of Participants With Microbiological Response at EOIV	End of Intravenous treatment (Day 5 up to Day 28)	Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up	Week 2 Follow-up	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up	Week 2 follow-up	Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up	Week 2 Follow-up	Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])	Week 6 Follow-up (EOS)	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)	Week 6 follow-up (EOS)	Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)	Week 6 Follow-up (EOS)	Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline	End of Treatment (Day 5 up to Day 42)	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline	End of Intravenous treatment (Day 5 up to Day 28)	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline	Week 2 Follow-up	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline	Week 6 Follow-up (EOS)	Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species	Baseline (Day 1) up to Week 6 Follow-up (EOS)	Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was \> 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.
Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)	Baseline up to 6 Week Follow-up (EOS)	Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)	Baseline up to 6 Week Follow-up (EOS)	Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)	Baseline up to End of Intravenous treatment (Day 5 up to Day 28)	Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)	Baseline up to End of Treatment (Day 5 up to Day 42)	Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.
Number of Participants Per Specified Cause of Death	Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)	Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with \> 1 cause of death if multiple causes were present.
Number of Participants With Non-serious and Serious Adverse Events	Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)	AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.
Number of Participants Who Died	Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Seoul, Korea, Republic of