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CompletedNCT00548262Updated Jan 17, 2011Results posted

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

A Phase 4 interventional study of Anidulafungin and Voriconazole in Candidemia and Invasive Candidiasis, sponsored by Pfizer. Completed at 13 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-17.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
54
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

02

Conditions studied

  • Candidemia
  • Invasive Candidiasis

Keywords

  • Open-label
  • non-comparative study to evaluate short course of IV anidulafungin
  • followed by oral voriconazole
  • for tx of candidemia/invasive candidiasis.
03

In context

Candidiasis

265 studies on the registry are indexed under Candidiasis; 20 are open to participants now.

This study's enrollment of 54 is below the median of 99 across 186 interventional studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male or female patient 18 years of age and older.
  • If female, must be post-menopausal, surgically sterile or using adequate contraception,not lactating, and have a negative urine or blood pregnancy test at screening, prior to administration of study medication.
  • 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 to study entry ((informed consent provided).

  • Presence of one or more of the following signs and symptoms of acute fungal infection within the prior 48 hours to initiation of study treatment:

    • Fever defined as oral temperature greater than or equal to 38 degrees C (100.4 degrees F); rectal or core temperature greater than or equal to 38.6 degrees C (101.4 degrees F), or axillary temperature greater than or equal to 37.5 degrees Celsius (99.5 degrees F). Hypothermia defined as rectal or core temperature less than 36.0 degrees C (96.8 degrees F).
    • Hypotension (systolic blood pressure [SBP] less than 100 mmHg, or SBP decrease greater than or equal to 30 mm Hg from baseline.
    • Localized signs and symptoms of inflammation (swelling, heat, erythema or purulence at a site infected with Candida spp.).
  • Patient is classified in one of following categories based on previous antifungal treatment: received less than 48 hours of previous systemic antifungal therapy and no more than a single dose of echinocandin therapy prior to study entry; intolerant to infusion related toxicities of amphotericin B preparations despite appropriate supportive measures or serum creatinine increased by >1.5 mg/dl while receiving conventional or lipid amphotericin B therapy; or lack of clinical response and/or persistent positive blood culture after at least seven days of systemic antifungal treatment with a polyene or fluconazole at an adequate dose.
  • APACHE II 9 score \< 25 at study entry.
  • Patients willing and able to give informed consent, or have a legally authorized representative willing to give informed consent on the patients behalf.
  • Expected survival (in the opinion of the investigator) greater than 4 days.

Exclusion criteria

Exclusion Criteria:

  • Hypersensitivity to anidulafungin, other echinocandins or azoles.
  • Participation presently or within the last 30 days in a trial with other investigational drug(s). Patients on antiretroviral or chemotherapy regimens which include an investigational drug may participate provided that there has been no change in their therapy during the past 4 weeks and no change in treatment is anticipated during study participation.
  • Chronic refractory neutropenia defined as absolute neutrophils count \<500 cells/mm3 for 28 days prior to the baseline visit.
  • Confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
  • Poor venous access that would preclude IV drug delivery or multiple blood draws.
  • Prosthetic devices at a suspected site of infection unless the device is removed within 24 hours of study entry.
  • Fungal endophthalmitis confirmed by fundoscopy.
  • Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration that may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the Patient inappropriate for entry into this trial.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    1

    Drug: Anidulafungin · Drug: Voriconazole

Interventions

  • DrugAnidulafungin

    All patients will receive anidulafungin 200 mg IV dose on Day 1. On Day 2 and daily thereafter the patients will receive one daily IV dose of 100 mg of anidulafungin.

    Also known as: Eraxis

  • DrugVoriconazole

    Patients who complete a minimum of 5 days of IV treatment with anidulafungin may be switched to oral voriconazole 200 mg BID (or 100 mg BID if \<40 kg body weight) therapy on Day 5 and thereafter, starting with a loading dose of 400 mg BID (or 200 mg BID if \<40 kg body weight).

    Also known as: Vfend

06

What researchers measure

Primary outcomes

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

    Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or 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).

    Time frame: End of Treatment (EOT) (up to Day 42)

Secondary outcomes

  1. Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)

    Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or 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).

    Time frame: End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up

  2. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.

    Time frame: Baseline, EIVT (up to Day 42)

  3. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.

    Time frame: Baseline, EOT (up to Day 42)

  4. Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.

    Time frame: Baseline, Week 2 Follow-up

  5. Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Time frame: Baseline, EOT (up to Day 42)

  6. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Time frame: EIVT (up to Day 42)

  7. Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

    Time frame: Baseline, Week 2 Follow-up (F/U)

  8. Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score

    Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score \<20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.

    Time frame: EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up

  9. Number of Participants Per Survival Status (Alive or Dead) on Day 30

    Time frame: Day 30

  10. Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis

    Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.

    Time frame: Baseline to Week 6 Follow-up

  11. Time to Negative Blood, Specimen, or Tissue Culture

    Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).

    Time frame: Baseline to Week 2 Follow-up

  12. Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment

    Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.

    Time frame: Baseline to Day 42

  13. Length of Hospital Stay

    Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.

    Time frame: Baseline to Week 6 Follow-up

  14. Length of Stay in Intensive Care Unit (ICU)

    Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.

    Time frame: Baseline up to Week 6 Follow-up

  15. Change From Baseline in Vital Signs: Supine Blood Pressure

    Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).

    Time frame: Baseline to Week 2 Follow-up

  16. Change From Baseline in Vital Signs: Supine Heart Rate

    Supine heart rate measured as beats per minute (bpm).

    Time frame: Baseline to Week 2 Follow-up

  17. Change From Baseline in Vital Signs: Weight

    Weight measured as kilograms (kg).

    Time frame: Baseline to Week 2 Follow-up

  18. Change From Baseline in Vital Signs: Temperature

    Temperature measured as degrees of Celsius (C).

    Time frame: Baseline to Week 2 Follow-up

  19. Change From Baseline in Vital Signs: Respiration Rate

    Respiration rate measured as respirations per minute (resp/min).

    Time frame: Baseline to Week 2 Follow-up

  20. Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)

    Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).

    Time frame: Baseline to Week 2 Follow-up

  21. Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)

    Chemistry laboratory test data measured as international units per (IU/L).

    Time frame: Baseline to Week 2 Follow-up

07

Results

Posted Jan 17, 2011
Limitations and caveats
Protocol registration indicated timeframes for EIVT and/or Week 2 F/U for time to event, mortality, vital signs, and labs; however, analyses were continuous and reported from baseline to EIVT (up to Day 42), Week 2 F/U, or Week 6 telephone F/U visit.

Participant flow

Participant flow — Overall Study
MilestoneAnidulafungin-Voriconazole
Started54
Completed22
Not completed32
Withdrew: Death21
Withdrew: Adverse event2
Withdrew: Lack of efficacy4
Withdrew: Lost to follow-up1
Withdrew: Other3
Withdrew: Withdrawal by subject1

Outcome measures

PrimaryNumber of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment

Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or 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).

Time frame:
End of Treatment (EOT) (up to Day 42)
Reported as:
Number · participants
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment
participantsAnidulafungin-Voriconazole
Success26 (44.6 to 73.6)
Failure18 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 59.1 · 95% CI 44.6 to 73.695% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)

Clinical Success (cure=resolution of Candida signs and symptoms \[s/s\] or improvement=significant but incomplete resolution of s/s) or Failure (at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological Success (eradication=negative culture for baseline Candida species (spp) or presumed eradication=follow-up (f/u) culture not available (n/a) and clinical outcome defined as success) or 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).

Time frame:
End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up
Reported as:
Number · participants
Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure)
participantsAnidulafungin-Voriconazole
EIVT Success26 (44.6 to 73.6)
EIVT Failure18 (NA to NA)
Week 2 Follow-up Success21 (33.0 to 62.5)
Week 2 Follow-up Failure23 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 59.1 · 95% CI 44.6 to 73.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 47.7 · 95% CI 33.0 to 62.595% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EIVT was assessed per the type of Candida species that was isolated at the baseline visit.

Time frame:
Baseline, EIVT (up to Day 42)
Reported as:
Number · participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT
participantsAnidulafungin-Voriconazole
Candida albicans: Success11 (31.0 to 73.7)
Candida albicans: Failure10 (NA to NA)
Candida famata: Success1 (0.0 to 100.0)
Candida famata: Failure1 (NA to NA)
Candida glabrata: Success2 (13.3 to 100.0)
Candida glabrata: Failure1 (NA to NA)
Candida guilliermondii: Success1 (NA to NA)
Candida guilliermondii: Failure0 (NA to NA)
Candida krusei: Success2 (13.3 to 100.0)
Candida krusei: Failure1 (NA to NA)
Candida parapsilosis: Success1 (0.0 to 46.5)
Candida parapsilosis: Failure5 (NA to NA)
Candida pelliculosa: Success1 (NA to NA)
Candida pelliculosa: Failure0 (NA to NA)
Candida tropicalis: Success8 (55.2 to 100.0)
Candida tropicalis: Failure2 (NA to NA)
Unidentifiable: Success4 (20.5 to 93.8)
Unidentifiable: Failure3 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 52.4 · 95% CI 31.0 to 73.795% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 50.0 · 95% CI 0.0 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 16.7 · 95% CI 0.0 to 46.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 80.0 · 95% CI 55.2 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 57.1 · 95% CI 20.5 to 93.895% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at EOT was assessed per the type of Candida species that was isolated at the baseline visit.

Time frame:
Baseline, EOT (up to Day 42)
Reported as:
Number · participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT
participantsAnidulafungin-Voriconazole
Candida albicans: Success11 (31.0 to 73.7)
Candida albicans: Failure10 (NA to NA)
Candida famata: Success0 (NA to NA)
Candida famata: Failure2 (NA to NA)
Candida glabrata: Success2 (13.3 to 100.0)
Candida glabrata: Failure1 (NA to NA)
Candida guilliermondii: Success1 (NA to NA)
Candida guilliermondii: Failure0 (NA to NA)
Candida krusei: Success2 (13.3 to 100.0)
Candida krusei: Failure1 (NA to NA)
Candida parapsilosis: Success1 (0.0 to 46.5)
Candida parapsilosis: Failure5 (NA to NA)
Candida pelliculosa: Success1 (NA to NA)
Candida pelliculosa: Failure0 (NA to NA)
Candida tropicalis: Success8 (55.2 to 100.0)
Candida tropicalis: Failure2 (NA to NA)
Unidentifiable: Success4 (20.5 to 93.8)
Unidentifiable: Failure3 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 52.4 · 95% CI 31.0 to 73.795% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 16.7 · 95% CI 0.0 to 46.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 80.0 · 95% CI 55.2 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 57.1 · 95% CI 20.5 to 93.895% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response at Week 2 Follow-up was assessed per the type of Candida species that was isolated at the baseline visit.

Time frame:
Baseline, Week 2 Follow-up
Reported as:
Number · participants
Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up
participantsAnidulafungin-Voriconazole
Candida albicans: Success10 (26.3 to 69.0)
Candida albicans: Failure11 (NA to NA)
Candida famata: Success0 (NA to NA)
Candida famata: Failure2 (NA to NA)
Candida glabrata: Success3 (NA to NA)
Candida glabrata: Failure0 (NA to NA)
Candida guilliermondii: Success1 (NA to NA)
Candida guilliermondii: Failure0 (NA to NA)
Candida krusei: Success2 (13.3 to 100.0)
Candida krusei: Failure1 (NA to NA)
Candida parapsilosis: Success0 (NA to NA)
Candida parapsilosis: Failure6 (NA to NA)
Candida pelliculosa: Success1 (NA to NA)
Candida pelliculosa: Failure0 (NA to NA)
Candida tropicalis: Success7 (41.6 to 98.4)
Candida tropicalis: Failure3 (NA to NA)
Unidentifiable: Success2 (0.0 to 62.0)
Unidentifiable: Failure5 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 47.6 · 95% CI 26.3 to 69.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 70.0 · 95% CI 41.6 to 98.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 28.6 · 95% CI 0.0 to 62.095% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EOT was assessed for participants categorized with baseline risk factors (Yes or No status) for Intensive Care Unit (ICU) stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Time frame:
Baseline, EOT (up to Day 42)
Reported as:
Number · participants
Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT
participantsAnidulafungin-Voriconazole
ICU stay ≥ 4 days (Yes): Success18 (39.1 to 73.4)
ICU stay ≥ 4 days (Yes): Failure14 (NA to NA)
ICU stay ≥ 4 days (No): Success8 (40.0 to 93.3)
ICU stay ≥ 4 days (No): Failure4 (NA to NA)
Mechanical ventilation (Yes): Success18 (37.6 to 71.5)
Mechanical ventilation (Yes): Failure15 (NA to NA)
Mechanical ventilation (No): Success8 (46.4 to 99.0)
Mechanical ventilation (No): Failure3 (NA to NA)
Antibiotics (Yes): Success22 (40.8 to 72.0)
Antibiotics (Yes): Failure17 (NA to NA)
Antibiotics (No): Success4 (44.9 to 100.0)
Antibiotics (No): Failure1 (NA to NA)
CV Catheter (Yes): Success21 (39.5 to 71.1)
CV Catheter (Yes): Failure17 (NA to NA)
CV Catheter (No): Success5 (53.5 to 100.0)
CV Catheter (No): Failure1 (NA to NA)
TPN (Yes): Success5 (12.0 to 64.9)
TPN (Yes): Failure8 (NA to NA)
TPN (No): Success21 (51.3 to 84.2)
TPN (No): Failure10 (NA to NA)
Dialysis (Yes): Success3 (6.2 to 79.5)
Dialysis (Yes): Failure4 (NA to NA)
Dialysis (No): Success23 (46.5 to 77.8)
Dialysis (No): Failure14 (NA to NA)
Abdominal surgery (Yes): Success11 (35.7 to 80.1)
Abdominal surgery (Yes): Failure8 (NA to NA)
Abdominal surgery (No): Success15 (40.8 to 79.2)
Abdominal surgery (No): Failure10 (NA to NA)
Solid organ transplant (No): Success26 (44.6 to 73.6)
Solid organ transplant (No): Failure18 (NA to NA)
Renal insufficiency (Yes): Success3 (6.2 to 79.5)
Renal insufficiency (Yes): Failure4 (NA to NA)
Renal insufficiency (No): Success23 (46.5 to 77.8)
Renal insufficiency (No): Failure14 (NA to NA)
Chemotherapy (Yes): Success1 (NA to NA)
Chemotherapy (Yes): Failure0 (NA to NA)
Chemotherapy (No): Success25 (43.4 to 72.9)
Chemotherapy (No): Failure18 (NA to NA)
Pancreatitis (Yes): Success1 (0.0 to 55.1)
Pancreatitis (Yes): Failure4 (NA to NA)
Pancreatitis (No): Success25 (49.0 to 79.2)
Pancreatitis (No): Failure14 (NA to NA)
Systemic steroids/immunos (Yes): Success6 (21.7 to 78.3)
Systemic steroids/immunos (Yes): Failure6 (NA to NA)
Systemic steroids/immunos (No): Success20 (45.7 to 79.3)
Systemic steroids/immunos (No): Failure12 (NA to NA)
Neutropenic: Success2 (13.3 to 100.0)
Neutropenic: Failure1 (NA to NA)
Non-neutropenic: Success18 (44.4 to 79.7)
Non-neutropenic: Failure11 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 56.3 · 95% CI 39.1 to 73.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 40.0 to 93.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 54.5 · 95% CI 37.6 to 71.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 72.7 · 95% CI 46.4 to 99.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 56.4 · 95% CI 40.8 to 72.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 80.0 · 95% CI 44.9 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 55.3 · 95% CI 39.5 to 71.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 83.3 · 95% CI 53.5 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 38.5 · 95% CI 12.0 to 64.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 67.7 · 95% CI 51.3 to 84.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 42.9 · 95% CI 6.2 to 79.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.2 · 95% CI 46.5 to 77.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 57.9 · 95% CI 35.7 to 80.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 60.0 · 95% CI 40.8 to 79.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 59.1 · 95% CI 44.6 to 73.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 42.9 · 95% CI 6.2 to 79.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.2 · 95% CI 46.5 to 77.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 58.1 · 95% CI 43.4 to 72.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 20.0 · 95% CI 0.0 to 55.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 64.1 · 95% CI 49.0 to 79.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 50.0 · 95% CI 21.7 to 78.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.5 · 95% CI 45.7 to 79.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.1 · 95% CI 44.4 to 79.795% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at EIVT was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Time frame:
EIVT (up to Day 42)
Reported as:
Number · participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT
participantsAnidulafungin-Voriconazole
ICU stay ≥ 4 days (Yes): Success18 (39.1 to 73.4)
ICU stay ≥ 4 days (Yes): Failure14 (NA to NA)
ICU stay ≥ 4 days (No): Success8 (40.0 to 93.3)
ICU stay ≥ 4 days (No): Failure4 (NA to NA)
Mechanical ventilation (Yes): Success18 (37.6 to 71.5)
Mechanical ventilation (Yes): Failure15 (NA to NA)
Mechanical ventilation (No): Success8 (46.4 to 99.0)
Mechanical ventilation (No): Failure3 (NA to NA)
Antibiotics (Yes): Success22 (40.8 to 72.0)
Antibiotics (Yes): Failure17 (NA to NA)
Antibiotics (No): Success4 (44.9 to 100.0)
Antibiotics (No): Failure1 (NA to NA)
CV Catheter (Yes): Success21 (39.5 to 71.1)
CV Catheter (Yes): Failure17 (NA to NA)
CV Catheter (No): Success5 (53.5 to 100.0)
CV Catheter (No): Failure1 (NA to NA)
TPN (Yes): Success6 (19.1 to 73.3)
TPN (Yes): Failure7 (NA to NA)
TPN (No): Success20 (47.7 to 81.4)
TPN (No): Failure11 (NA to NA)
Dialysis (Yes): Success3 (6.2 to 79.5)
Dialysis (Yes): Failure4 (NA to NA)
Dialysis (No): Success23 (46.5 to 77.8)
Dialysis (No): Failure14 (NA to NA)
Abdominal surgery (Yes): Success12 (41.5 to 84.8)
Abdominal surgery (Yes): Failure7 (NA to NA)
Abdominal surgery (No): Success14 (36.5 to 75.5)
Abdominal surgery (No): Failure11 (NA to NA)
Solid organ transplant (No): Success26 (44.6 to 73.6)
Solid organ transplant (No): Failure18 (NA to NA)
Renal insufficiency (Yes): Success3 (6.2 to 79.5)
Renal insufficiency (Yes): Failure4 (NA to NA)
Renal insufficiency (No): Success23 (46.5 to 77.8)
Renal insufficiency (No): Failure14 (NA to NA)
Chemotherapy (Yes): Success1 (NA to NA)
Chemotherapy (Yes): Failure0 (NA to NA)
Chemotherapy (No): Success25 (43.4 to 72.9)
Chemotherapy (No): Failure18 (NA to NA)
Pancreatitis (Yes): Success2 (0.0 to 82.9)
Pancreatitis (Yes): Failure3 (NA to NA)
Pancreatitis (No): Success24 (46.3 to 76.8)
Pancreatitis (No): Failure15 (NA to NA)
Systemic steroids/immunos (Yes): Success7 (30.4 to 86.2)
Systemic steroids/immunos (Yes): Failure5 (NA to NA)
Systemic steroids/immunos (No): Success19 (42.4 to 76.4)
Systemic steroids/immunos (No): Failure13 (NA to NA)
Neutropenic: Success2 (13.3 to 100.0)
Neutropenic: Failure1 (NA to NA)
Non-neutropenic: Success18 (44.4 to 79.7)
Non-neutropenic: Failure11 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 56.3 · 95% CI 39.1 to 73.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 40.0 to 93.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 54.5 · 95% CI 37.6 to 71.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 72.7 · 95% CI 46.4 to 99.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 56.4 · 95% CI 40.8 to 72.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 80.0 · 95% CI 44.9 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 55.3 · 95% CI 39.5 to 71.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 83.3 · 95% CI 53.5 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 46.2 · 95% CI 19.1 to 73.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 64.5 · 95% CI 47.7 to 81.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 42.9 · 95% CI 6.2 to 79.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.2 · 95% CI 46.5 to 77.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 63.2 · 95% CI 41.5 to 84.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 56.0 · 95% CI 36.5 to 75.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 59.1 · 95% CI 44.6 to 73.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 42.9 · 95% CI 6.2 to 79.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.2 · 95% CI 46.5 to 77.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 58.1 · 95% CI 43.4 to 72.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 40.0 · 95% CI 0.0 to 82.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 61.5 · 95% CI 46.3 to 76.895% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 58.3 · 95% CI 30.4 to 86.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 59.4 · 95% CI 42.4 to 76.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 62.1 · 95% CI 44.4 to 79.795% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Global response at Week 2 F/U was assessed for participants categorized with baseline risk factors for Candidemia and Invasive Candidiasis: ICU stay ≥ 4 days, mechanical ventilation, broad spectrum antibiotics (antibiotics), central venous (CV) catheter, total parental nutrition (TPN), dialysis, abdominal surgery, solid organ transplant, renal insufficiency, chemotherapy, pancreatitis, systemic steroids or immunosuppressives (Systemic steroids/immunos), neutropenic status, or elderly.

Time frame:
Baseline, Week 2 Follow-up (F/U)
Reported as:
Number · participants
Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up
participantsAnidulafungin-Voriconazole
ICU stay ≥ 4 days (Yes): Success12 (20.7 to 54.3)
ICU stay ≥ 4 days (Yes): Failure20 (NA to NA)
ICU stay ≥ 4 days (No): Success9 (50.5 to 99.5)
ICU stay ≥ 4 days (No): Failure3 (NA to NA)
Mechanical ventilation (Yes): Success13 (22.7 to 56.1)
Mechanical ventilation (Yes): Failure20 (NA to NA)
Mechanical ventilation (No): Success8 (46.4 to 99.0)
Mechanical ventilation (No): Failure3 (NA to NA)
Antibiotics (Yes): Success19 (33.0 to 64.4)
Antibiotics (Yes): Failure20 (NA to NA)
Antibiotics (No): Success2 (0.0 to 82.9)
Antibiotics (No): Failure3 (NA to NA)
CV Catheter (Yes): Success18 (31.5 to 63.2)
CV Catheter (Yes): Failure20 (NA to NA)
CV Catheter (No): Success3 (10.0 to 90.0)
CV Catheter (No): Failure3 (NA to NA)
TPN (Yes): Success5 (12.0 to 64.9)
TPN (Yes): Failure8 (NA to NA)
TPN (No): Success16 (34.0 to 69.2)
TPN (No): Failure15 (NA to NA)
Dialysis (Yes): Success1 (0.0 to 40.2)
Dialysis (Yes): Failure6 (NA to NA)
Dialysis (No): Success20 (38.0 to 70.1)
Dialysis (No): Failure17 (NA to NA)
Abdominal surgery (Yes): Success8 (19.9 to 64.3)
Abdominal surgery (Yes): Failure11 (NA to NA)
Abdominal surgery (No): Success13 (32.4 to 71.6)
Abdominal surgery (No): Failure12 (NA to NA)
Solid organ transplant (No): Success21 (33.0 to 62.5)
Solid organ transplant (No): Failure23 (NA to NA)
Renal insufficiency (Yes): Success1 (0.0 to 40.2)
Renal insufficiency (Yes): Failure6 (NA to NA)
Renal insufficiency (No): Success20 (38.0 to 70.1)
Renal insufficiency (No): Failure17 (NA to NA)
Chemotherapy (Yes): Success1 (NA to NA)
Chemotherapy (Yes): Failure0 (NA to NA)
Chemotherapy (No): Success20 (31.6 to 61.4)
Chemotherapy (No): Failure23 (NA to NA)
Pancreatitis (Yes): Success2 (0.0 to 82.9)
Pancreatitis (Yes): Failure3 (NA to NA)
Pancreatitis (No): Success19 (33.0 to 64.4)
Pancreatitis (No): Failure20 (NA to NA)
Systemic steroids/immunos (Yes): Success5 (13.8 to 69.6)
Systemic steroids/immunos (Yes): Failure7 (NA to NA)
Systemic steroids/immunos (No): Success16 (32.7 to 67.3)
Systemic steroids/immunos (No): Failure16 (NA to NA)
Neutropenic: Success2 (13.3 to 100.0)
Neutropenic: Failure1 (NA to NA)
Non-neutropenic: Success15 (33.5 to 69.9)
Non-neutropenic: Failure14 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 37.5 · 95% CI 20.7 to 54.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 75.0 · 95% CI 50.5 to 99.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 39.4 · 95% CI 22.7 to 56.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 72.7 · 95% CI 46.4 to 99.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 48.7 · 95% CI 33.0 to 64.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 40.0 · 95% CI 0.0 to 82.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 47.4 · 95% CI 31.5 to 63.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 50.0 · 95% CI 10.0 to 90.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 38.5 · 95% CI 12.0 to 64.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 51.6 · 95% CI 34.0 to 69.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 14.3 · 95% CI 0.0 to 40.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 54.1 · 95% CI 38.0 to 70.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 42.1 · 95% CI 19.9 to 64.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 52.0 · 95% CI 32.4 to 71.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 47.7 · 95% CI 33.0 to 62.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 14.3 · 95% CI 0.0 to 40.295% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 54.1 · 95% CI 38.0 to 70.195% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 46.5 · 95% CI 31.6 to 61.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 40.0 · 95% CI 0.0 to 82.995% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 48.7 · 95% CI 33.0 to 64.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 41.7 · 95% CI 13.8 to 69.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 50.0 · 95% CI 32.7 to 67.395% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 66.7 · 95% CI 13.3 to 100.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 51.7 · 95% CI 33.5 to 69.995% CI based on normal approximation to the binomial.
SecondaryNumber of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score

Global response based on assessments of Clinical Success or Failure and Microbiological Success or Failure. Categorized as global Success if both clinical and microbiological response=success; Failure defined as all other combinations. Global response assessed as APACHE II score \<20 (less affected) or ≥20 (more severe). APACHE II assesses severity of illness in acutely ill participants; measurements computed for physiologic variables were transformed to integer score ranging 0 (normal) to 71 (more severe). Higher scores indicate more severe disease and higher risk of death.

Time frame:
EIVT (up to Day 42), EOT (up to Day 42), Week 2 Follow-up
Reported as:
Number · participants
Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score
participantsAnidulafungin-Voriconazole
APACHE <20 (EIVT): Success24 (53.2 to 84.0)
APACHE <20 (EIVT): Failure11 (NA to NA)
APACHE ≥20 (EIVT): Success2 (0.0 to 49.4)
APACHE ≥20 (EIVT): Failure7 (NA to NA)
APACHE <20 (EOT): Success25 (56.5 to 86.4)
APACHE <20 (EOT): Failure10 (NA to NA)
APACHE ≥20 (EOT): Success1 (0.0 to 31.6)
APACHE ≥20 (EOT): Failure8 (NA to NA)
APACHE <20 (Week 2 F/U): Success20 (40.7 to 73.5)
APACHE <20 (Week 2 F/U): Failure15 (NA to NA)
APACHE ≥20 (Week 2 F/U): Success1 (0.0 to 31.6)
APACHE ≥20 (Week 2 F/U): Failure8 (NA to NA)
Statistical analysis
  • Anidulafungin-Voriconazole · Percentage of participants with success: 68.6 · 95% CI 53.2 to 84.095% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 22.2 · 95% CI 0.0 to 49.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 71.4 · 95% CI 56.5 to 86.495% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 11.1 · 95% CI 0.0 to 31.695% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 57.1 · 95% CI 40.7 to 73.595% CI based on normal approximation to the binomial.
  • Anidulafungin-Voriconazole · Percentage of participants with success: 11.1 · 95% CI 0.0 to 31.695% CI based on normal approximation to the binomial.
SecondaryNumber of Participants Per Survival Status (Alive or Dead) on Day 30
Time frame:
Day 30
Reported as:
Number · participants
Number of Participants Per Survival Status (Alive or Dead) on Day 30
participantsAnidulafungin-Voriconazole
Alive25
Dead19
SecondaryNumber of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis

Death is attributable to Candidemia or Invasive Candidiasis if investigator recorded "disease under study" as cause of death. Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam). Week 6 Follow-up visit conducted by phone.

Time frame:
Baseline to Week 6 Follow-up
Reported as:
Number · participants
Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis
participantsAnidulafungin-Voriconazole
Attributable death (Yes)4
Attributable death (No)19
SecondaryTime to Negative Blood, Specimen, or Tissue Culture

Defined as time from first drug administratin to date of earliest recorded documentation of negative blood, specimen, or tissue culture (absence of Candidemia or Invasive Candidiasis). Candidemia (positive blood culture) or Invasive Cadidiasis (yeast cells in histopathological or cytopathological exam).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Number · Days

No measurements were reported for this outcome.

SecondaryDuration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment

Defined as time in days from first intravenous administration of Anidulafungin to the date of earliest recorded documentation of switch to oral Voriconazole treatment. Participants received at least 5 days (and a maximum of 42 days) of IV Anidulafungin; after this, they may continue treatment with oral Voriconazole for at least 14 days from the day of last positive culture up to a maximum of 42 days.

Time frame:
Baseline to Day 42
Reported as:
Median · days
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment
daysAnidulafungin-Voriconazole
Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment10.0 (1 to 28)
SecondaryLength of Hospital Stay

Defined as the number of days from date of first drug administration to date of first hospital discharge if participant was discharged to home or other location. Week 6 Follow-up visit conducted by phone.

Time frame:
Baseline to Week 6 Follow-up
Reported as:
Number · days

No measurements were reported for this outcome.

SecondaryLength of Stay in Intensive Care Unit (ICU)

Defined as the number of days from date of first drug administration to date of first ICU discharge. Week 6 Follow-up visit conducted by phone.

Time frame:
Baseline up to Week 6 Follow-up
Reported as:
Median · Days
Length of Stay in Intensive Care Unit (ICU)
DaysAnidulafungin-Voriconazole
Length of Stay in Intensive Care Unit (ICU)16.0 (8.0 to 29.0)
SecondaryChange From Baseline in Vital Signs: Supine Blood Pressure

Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · mmHg
Change From Baseline in Vital Signs: Supine Blood Pressure
mmHgAnidulafungin-Voriconazole
Baseline median: supine systolic BP120.0 (NA to NA)
Change from baseline: supine systolic BP0.00 (NA to NA)
Baseline median: supine diastolic BP66.0 (NA to NA)
Change from baseline: supine diastolic BP0.00 (NA to NA)
SecondaryChange From Baseline in Vital Signs: Supine Heart Rate

Supine heart rate measured as beats per minute (bpm).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · bpm
Change From Baseline in Vital Signs: Supine Heart Rate
bpmAnidulafungin-Voriconazole
Baseline median: supine heart rate97.5 (NA to NA)
Change from baseline: supine heart rate3.00 (NA to NA)
SecondaryChange From Baseline in Vital Signs: Weight

Weight measured as kilograms (kg).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · kg
Change From Baseline in Vital Signs: Weight
kgAnidulafungin-Voriconazole
Baseline median: weight65.0 (NA to NA)
Change from baseline: weight-0.70 (NA to NA)
SecondaryChange From Baseline in Vital Signs: Temperature

Temperature measured as degrees of Celsius (C).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · Degrees of Celsius
Change From Baseline in Vital Signs: Temperature
Degrees of CelsiusAnidulafungin-Voriconazole
Baseline median: temperature37.5 (NA to NA)
Change from baseline: temperature-0.30 (NA to NA)
SecondaryChange From Baseline in Vital Signs: Respiration Rate

Respiration rate measured as respirations per minute (resp/min).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · resp/min
Change From Baseline in Vital Signs: Respiration Rate
resp/minAnidulafungin-Voriconazole
Baseline median: respiration rate20.0 (NA to NA)
Change from baseline: respiration rate-0.50 (NA to NA)
SecondaryChange From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)

Chemistry laboratory test data measured as milligrams per deciliter (mg/dL).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · mg/dL
Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL)
mg/dLAnidulafungin-Voriconazole
Baseline median: total bilirubin (n=19)0.6 (NA to NA)
Change from baseline: total bilirubin-0.2 (NA to NA)
Baseline median: direct bilirubin (n=19)0.2 (NA to NA)
Change from baseline: direct bilirubin-0.1 (NA to NA)
Baseline median: indirect bilirubin (n=17)0.3 (NA to NA)
Change from baseline: indirect bilirubin0.0 (NA to NA)
Baseline median: blood urea nitrogen (n=25)37.4 (NA to NA)
Change from baseline: blood urea nitrogen-4.8 (NA to NA)
Baseline median: creatinine (n=27)0.8 (NA to NA)
Change from baseline: creatinine0.0 (NA to NA)
Baseline median: glucose (n=24)99 (NA to NA)
Change from baseline: glucose-6 (NA to NA)
SecondaryChange From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)

Chemistry laboratory test data measured as international units per (IU/L).

Time frame:
Baseline to Week 2 Follow-up
Reported as:
Median · IU/L
Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L)
IU/LAnidulafungin-Voriconazole
Baseline median: aspartate aminotransferase (n=18)43 (NA to NA)
Change from baseline: aspartate aminotransferase-18 (NA to NA)
Baseline median: alanine aminotransferase (n=16)45 (NA to NA)
Change from baseline: alanine aminotransferase-5 (NA to NA)
Baseline median: lactate dehydrogenase (n=13)536 (NA to NA)
Change from baseline: lactate dehydrogenase-160 (NA to NA)
Baseline median: alkaline phosphatase (n=17)114 (NA to NA)
Change from baseline: alkaline phosphatase26 (NA to NA)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Anidulafungin-Voriconazole—29/54 (53.7%)26/54 (48.1%)
Most frequent serious events
Showing 10 of 50
Most frequent serious events
EventAnidulafungin-Voriconazole
Septic shockInfections and infestations11/54
Cardio-respiratory arrestCardiac disorders4/54
Multi-organ disorderGeneral disorders4/54
DeathGeneral disorders3/54
Acute respiratory failureRespiratory, thoracic and mediastinal disorders3/54
Cardiac arrestCardiac disorders2/54
Renal failureRenal and urinary disorders2/54
HypotensionVascular disorders2/54
Shock haemorrhagicVascular disorders2/54
Blood disorderBlood and lymphatic system disorders1/54
Most frequent other events
Showing 10 of 12
Most frequent other events
EventAnidulafungin-Voriconazole
HypokalaemiaMetabolism and nutrition disorders10/54
AnaemiaBlood and lymphatic system disorders5/54
PyrexiaGeneral disorders4/54
HypertensionVascular disorders4/54
LeukopeniaBlood and lymphatic system disorders3/54
ThrombocytopeniaBlood and lymphatic system disorders3/54
DiarrhoeaGastrointestinal disorders3/54
VomitingGastrointestinal disorders3/54
HyperglycaemiaMetabolism and nutrition disorders3/54
HyperkalaemiaMetabolism and nutrition disorders3/54

Baseline characteristics

Age, Customized
Age, Customized(participants)Anidulafungin-Voriconazole
Between 18 and 44 years18
Between 45 and 64 years18
≥ 65 years18
Sex: Female, Male
Sex: Female, Male(Participants)Anidulafungin-Voriconazole
Female32
Male22
08

Study locations

13 sites
  • Pfizer Investigational Site
    Brasilia, DF 70710-905, Brazil
  • Pfizer Investigational Site
    Curitiba, PR 80060-900, Brazil
  • Pfizer Investigational Site
    Rio de Janeiro, RJ 21941-913, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90020-090, Brazil
  • Pfizer Investigational Site
    Porto Alegre, RS 90110-270, Brazil
  • Pfizer Investigational Site
    Sao Jose do Rio Preto, SP 15090-000, Brazil
  • Pfizer Investigational Site
    Independencia, Santiago, RM 8380456, Chile
  • Pfizer Investigational Site
    Bogota DC, Cundinamarca 0000, Colombia
  • Pfizer Investigational Site
    Cali, Valle Del Cauca 0000, Colombia
  • Pfizer Investigational Site
    Leon, Guanajuato 37320, Mexico
  • Pfizer Investigational Site
    Guadalajara, Jalisco 44280, Mexico
  • Pfizer Investigational Site
    San Luis Potosi, 78240, Mexico
  • Pfizer Investigational Site
    Panama, Panama
09

References and documents

Publications

  • De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23. PubMed 33891293 ↗
  • Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6. PubMed 31280481 ↗
  • Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9. PubMed 28597967 ↗
  • Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116. PubMed 28459966 ↗
  • Nucci M, Colombo AL, Petti M, Magana M, Abreu P, Schlamm HT, Sanchez SP. An open-label study of anidulafungin for the treatment of candidaemia/invasive candidiasis in Latin America. Mycoses. 2014 Jan;57(1):12-8. doi: 10.1111/myc.12094. Epub 2013 May 26. PubMed 23710653 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00548262
Lead sponsor
Pfizer
First posted
Oct 23, 2007
Start date
Feb 2008
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Jan 17, 2011
Last update
Jan 17, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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