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Completed

NCT Number: NCT00496197

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

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.

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Key information

Conditions

Candidiasis Bacterial Infections and Mycoses Candidemia Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, Seoul, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Eraxis (anidulafungin)

Drug

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Diflucan (fluconazole)

Drug

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.

Vfend (voriconazole)

Drug

Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.

Primary outcomes

  1. Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)

    Time frame: 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 outcomes

  1. Number of Participants With Clinical Response at EOT

    Time frame: 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.

  2. Number of Participants With Microbiological Response at EOT

    Time frame: 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).

  3. Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)

    Time frame: 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).

  4. Number of Participants With Clinical Response at EOIV

    Time frame: 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.

  5. Number of Participants With Microbiological Response at EOIV

    Time frame: 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).

  6. Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up

    Time frame: 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).

  7. Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up

    Time frame: 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.

  8. Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up

    Time frame: 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).

  9. 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])

    Time frame: 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).

  10. Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)

    Time frame: 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.

  11. Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)

    Time frame: 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).

  12. 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

    Time frame: 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).

  13. 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

    Time frame: 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).

  14. 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

    Time frame: 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).

  15. 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

    Time frame: 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).

  16. Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species

    Time frame: 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.

  17. Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)

    Time frame: 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.

  18. Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)

    Time frame: Baseline up to 6 Week Follow-up (EOS)

    Analysis of length of hospital stay based on Kaplan-Meier survival techniques.

  19. Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)

    Time frame: 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.

  20. Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)

    Time frame: 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.

  21. Number of Participants Per Specified Cause of Death

    Time frame: 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.

  22. Number of Participants With Non-serious and Serious Adverse Events

    Time frame: 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.

  23. Number of Participants Who Died

    Time frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 4, 2007
Registry last updated
Oct 3, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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