Candidemia, Invasive Candidiasis
Conditions
Keywords
Open-label, non-comparative study to evaluate short course of IV anidulafungin, followed by oral voriconazole, for tx of candidemia/invasive candidiasis.
Brief 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.
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.
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).
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment | End of Treatment (EOT) (up to Day 42) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | End of Intravenous Treatment (EIVT) (up to Day 42), Week 2 Follow-up | 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). |
| Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Baseline, EIVT (up to Day 42) | 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. |
| Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Baseline, EOT (up to Day 42) | 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. |
| Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Baseline, EOT (up to Day 42) | 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. |
| Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | EIVT (up to Day 42) | 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. |
| Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Baseline, Week 2 Follow-up (F/U) | 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. |
| Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | EIVT (up to Day 42), EOT (up to Day 42), 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 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. |
| Number of Participants Per Survival Status (Alive or Dead) on Day 30 | Day 30 | — |
| Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis | Baseline to Week 6 Follow-up | 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 to Negative Blood, Specimen, or Tissue Culture | Baseline to Week 2 Follow-up | 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). |
| Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | 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. |
| Length of Hospital Stay | Baseline to Week 6 Follow-up | 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. |
| Length of Stay in Intensive Care Unit (ICU) | Baseline up to Week 6 Follow-up | 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. |
| Change From Baseline in Vital Signs: Supine Blood Pressure | Baseline to Week 2 Follow-up | Supine systolic and diastolic blood pressure BP) measured as millimeters of mercury (mmHg). |
| Change From Baseline in Vital Signs: Supine Heart Rate | Baseline to Week 2 Follow-up | Supine heart rate measured as beats per minute (bpm). |
| Change From Baseline in Vital Signs: Weight | Baseline to Week 2 Follow-up | Weight measured as kilograms (kg). |
| Change From Baseline in Vital Signs: Temperature | Baseline to Week 2 Follow-up | Temperature measured as degrees of Celsius (C). |
| Change From Baseline in Vital Signs: Respiration Rate | Baseline to Week 2 Follow-up | Respiration rate measured as respirations per minute (resp/min). |
| Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline to Week 2 Follow-up | Chemistry laboratory test data measured as milligrams per deciliter (mg/dL). |
| Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Baseline to Week 2 Follow-up | Chemistry laboratory test data measured as international units per (IU/L). |
| Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment | Baseline to Day 42 | 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. |
Countries
Brazil, Chile, Colombia, Mexico, Panama
Participant flow
Pre-assignment details
The planned sample size for this study was 210 subjects; however, due to slow enrollment, only 54 subjects were screened and randomized.
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin-Voriconazole Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily \[BID\] or 200 mg BID if body weight \< 40 kilograms \[kg\] and then 200 mg BID or 100 mg BID if body weight \< 40 kg thereafter. | 54 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 21 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Anidulafungin-Voriconazole |
|---|---|
| Age, Customized ≥ 65 years | 18 participants |
| Age, Customized Between 18 and 44 years | 18 participants |
| Age, Customized Between 45 and 64 years | 18 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 26 / 54 |
| serious Total, serious adverse events | 29 / 54 |
Outcome results
Primary
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)
Population: Modified Intent-to-Treat population (MITT): all Intent-to-Treat (ITT) participants (took at least 1 dose of study treatment) and with a positive baseline culture for a Candida spp within 96 hours before entry into the study. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment | Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) at End of Treatment | Success | 26 participants |
Comparison: Success at EOT95% CI: [44.6, 73.6]
Secondary
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
Population: Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Change from baseline: alkaline phosphatase | 26 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Baseline median: aspartate aminotransferase (n=18) | 43 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Change from baseline: aspartate aminotransferase | -18 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Baseline median: alanine aminotransferase (n=16) | 45 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Change from baseline: alanine aminotransferase | -5 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Baseline median: lactate dehydrogenase (n=13) | 536 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Change from baseline: lactate dehydrogenase | -160 IU/L |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as IU/L) | Baseline median: alkaline phosphatase (n=17) | 114 IU/L |
Secondary
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
Population: Safety analysis population; N=number of participants with analyzable laboratory data; (n)=number of subjects with data for each test at observation.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: total bilirubin (n=19) | 0.6 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: total bilirubin | -0.2 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: direct bilirubin (n=19) | 0.2 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: direct bilirubin | -0.1 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: indirect bilirubin (n=17) | 0.3 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: indirect bilirubin | 0.0 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: blood urea nitrogen (n=25) | 37.4 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: blood urea nitrogen | -4.8 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: creatinine (n=27) | 0.8 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: creatinine | 0.0 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Baseline median: glucose (n=24) | 99 mg/dL |
| Anidulafungin-Voriconazole | Change From Baseline in Chemistry Laboratory Test Data (Measured as mg/dL) | Change from baseline: glucose | -6 mg/dL |
Secondary
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
Population: Safety analysis population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Respiration Rate | Baseline median: respiration rate | 20.0 resp/min |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Respiration Rate | Change from baseline: respiration rate | -0.50 resp/min |
Secondary
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
Population: Safety analysis population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Blood Pressure | Baseline median: supine systolic BP | 120.0 mmHg |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Blood Pressure | Change from baseline: supine systolic BP | 0.00 mmHg |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Blood Pressure | Baseline median: supine diastolic BP | 66.0 mmHg |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Blood Pressure | Change from baseline: supine diastolic BP | 0.00 mmHg |
Secondary
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
Population: Safety analysis population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Heart Rate | Baseline median: supine heart rate | 97.5 bpm |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Supine Heart Rate | Change from baseline: supine heart rate | 3.00 bpm |
Secondary
Change From Baseline in Vital Signs: Temperature
Temperature measured as degrees of Celsius (C).
Time frame: Baseline to Week 2 Follow-up
Population: Safety analysis population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Temperature | Baseline median: temperature | 37.5 Degrees of Celsius |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Temperature | Change from baseline: temperature | -0.30 Degrees of Celsius |
Secondary
Change From Baseline in Vital Signs: Weight
Weight measured as kilograms (kg).
Time frame: Baseline to Week 2 Follow-up
Population: Safety analysis population; N=number of participants with evaluable data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Weight | Baseline median: weight | 65.0 kg |
| Anidulafungin-Voriconazole | Change From Baseline in Vital Signs: Weight | Change from baseline: weight | -0.70 kg |
Secondary
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
Population: Safety analysis set: all participants who received any dose of study medication.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anidulafungin-Voriconazole | Duration of Exposure to Intravenous Anidulafungin Prior to Switch to Oral Voriconazole Treatment | 10.0 days |
Secondary
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
Population: MITT; data not summarized using descriptive statistics.
Secondary
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
Population: MITT; N=number of participants evaluable for length of time in ICU.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anidulafungin-Voriconazole | Length of Stay in Intensive Care Unit (ICU) | 16.0 Days |
Secondary
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
Population: MITT. Success=clinical and microbiological success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | EIVT Success | 26 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | EIVT Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | Week 2 Follow-up Success | 21 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response (Based on Clinical and Microbiological Success or Failure) | Week 2 Follow-up Failure | 23 participants |
Comparison: EIVT Success95% CI: [44.6, 73.6]
Comparison: Week 2 Follow-up Success95% CI: [33, 62.5]
Secondary
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
Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (EIVT): Success | 24 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (EIVT): Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (EIVT): Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (EIVT): Failure | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (EOT): Success | 25 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (EOT): Failure | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (EOT): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (EOT): Failure | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (Week 2 F/U): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE <20 (Week 2 F/U): Failure | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (Week 2 F/U): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response by Acute Physiological Assessment and Chronic Health Evaluation II (APACHE II) Score | APACHE ≥20 (Week 2 F/U): Failure | 8 participants |
Comparison: APACHE \<20 (EIVT): Success95% CI: [53.2, 84]
Comparison: APACHE ≥20 (EIVT): Success95% CI: [0, 49.4]
Comparison: APACHE \<20 (EOT): Success95% CI: [56.5, 86.4]
Comparison: APACHE ≥20 (EOT): Success95% CI: [0, 31.6]
Comparison: APACHE \<20 (Week 2 F/U): Success95% CI: [40.7, 73.5]
Comparison: APACHE ≥20 (Week 2 F/U): Success95% CI: [0, 31.6]
Secondary
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)
Population: MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly \>65 years of age; not summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Dialysis (Yes): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Abdominal surgery (Yes): Failure | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | ICU stay ≥ 4 days (No): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Mechanical ventilation (Yes): Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Mechanical ventilation (Yes): Failure | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Mechanical ventilation (No): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Mechanical ventilation (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Antibiotics (Yes): Success | 22 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Antibiotics (Yes): Failure | 17 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Antibiotics (No): Success | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | CV Catheter (No): Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | TPN (Yes): Success | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | TPN (Yes): Failure | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | TPN (No): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | TPN (No): Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Dialysis (Yes): Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Abdominal surgery (No): Success | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Abdominal surgery (No): Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Solid organ transplant (No): Success | 26 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Solid organ transplant (No): Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Renal insufficiency (Yes): Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Renal insufficiency (Yes): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Renal insufficiency (No): Success | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Renal insufficiency (No): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Chemotherapy (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Chemotherapy (Yes): Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Chemotherapy (No): Success | 25 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Chemotherapy (No): Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Pancreatitis (Yes): Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Pancreatitis (Yes): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Pancreatitis (No): Success | 24 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Pancreatitis (No): Failure | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Systemic steroids/immunos (Yes): Success | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Systemic steroids/immunos (Yes): Failure | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Systemic steroids/immunos (No): Success | 19 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Systemic steroids/immunos (No): Failure | 13 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Neutropenic: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Neutropenic: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Non-neutropenic: Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Non-neutropenic: Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | ICU stay ≥ 4 days (Yes): Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | ICU stay ≥ 4 days (Yes): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | ICU stay ≥ 4 days (No): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Antibiotics (No): Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | CV Catheter (Yes): Success | 21 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | CV Catheter (Yes): Failure | 17 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | CV Catheter (No): Success | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Dialysis (No): Success | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Dialysis (No): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: EIVT | Abdominal surgery (Yes): Success | 12 participants |
Comparison: ICU stay ≥ 4 days (Yes): Success95% CI: [39.1, 73.4]
Comparison: ICU stay ≥ 4 days (No): Success95% CI: [40, 93.3]
Comparison: Mechanical ventilation (Yes): Success95% CI: [37.6, 71.5]
Comparison: Mechanical ventilation (No): Success95% CI: [46.4, 99]
Comparison: Antibiotics (Yes): Success95% CI: [40.8, 72]
Comparison: Antibiotics (No): Success95% CI: [44.9, 100]
Comparison: CV Catheter (Yes): Success95% CI: [39.5, 71.1]
Comparison: CV Catheter (No): Success95% CI: [53.5, 100]
Comparison: TPN (Yes): Success95% CI: [19.1, 73.3]
Comparison: TPN (No): Success95% CI: [47.7, 81.4]
Comparison: Dialysis (Yes): Success95% CI: [6.2, 79.5]
Comparison: Dialysis (No): Success95% CI: [46.5, 77.8]
Comparison: Abdominal surgery (Yes): Success95% CI: [41.5, 84.8]
Comparison: Abdominal surgery (No): Success95% CI: [36.5, 75.5]
Comparison: Solid organ transplant (No): Success95% CI: [44.6, 73.6]
Comparison: Renal insufficiency (Yes): Success95% CI: [6.2, 79.5]
Comparison: Renal insufficiency (No): Success95% CI: [46.5, 77.8]
Comparison: Chemotherapy (No): Success95% CI: [43.4, 72.9]
Comparison: Pancreatitis (Yes): Success95% CI: [0, 82.9]
Comparison: Pancreatitis (No): Success95% CI: [46.3, 76.8]
Comparison: Systemic steroids/immunos (Yes): Success95% CI: [30.4, 86.2]
Comparison: Systemic steroids/immunos (No): Success95% CI: [42.4, 76.4]
Comparison: Neutropenic: Success95% CI: [13.3, 100]
Comparison: Non-neutropenic: Success95% CI: [44.4, 79.7]
Secondary
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)
Population: MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data insufficient for analysis by status=elderly \>65 years of age; not summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Abdominal surgery (No): Failure | 12 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | ICU stay ≥ 4 days (Yes): Success | 12 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | ICU stay ≥ 4 days (Yes): Failure | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | ICU stay ≥ 4 days (No): Success | 9 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | ICU stay ≥ 4 days (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Mechanical ventilation (Yes): Success | 13 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Mechanical ventilation (Yes): Failure | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Mechanical ventilation (No): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Mechanical ventilation (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Antibiotics (Yes): Success | 19 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Antibiotics (Yes): Failure | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Antibiotics (No): Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Antibiotics (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | CV Catheter (Yes): Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | CV Catheter (Yes): Failure | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | CV Catheter (No): Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | CV Catheter (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | TPN (Yes): Success | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | TPN (Yes): Failure | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | TPN (No): Success | 16 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | TPN (No): Failure | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Dialysis (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Dialysis (Yes): Failure | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Dialysis (No): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Dialysis (No): Failure | 17 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Abdominal surgery (Yes): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Abdominal surgery (Yes): Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Abdominal surgery (No): Success | 13 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Solid organ transplant (No): Success | 21 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Solid organ transplant (No): Failure | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Renal insufficiency (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Renal insufficiency (Yes): Failure | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Renal insufficiency (No): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Renal insufficiency (No): Failure | 17 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Chemotherapy (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Chemotherapy (Yes): Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Chemotherapy (No): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Chemotherapy (No): Failure | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Pancreatitis (Yes): Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Pancreatitis (Yes): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Pancreatitis (No): Success | 19 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Pancreatitis (No): Failure | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Systemic steroids/immunos (Yes): Success | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Systemic steroids/immunos (Yes): Failure | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Systemic steroids/immunos (No): Success | 16 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Systemic steroids/immunos (No): Failure | 16 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Neutropenic: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Neutropenic: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Non-neutropenic: Success | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Baseline Risk Factors for Candidemia and Invasive Candidiasis: Week 2 Follow-up | Non-neutropenic: Failure | 14 participants |
Comparison: ICU stay ≥ 4 days (Yes): Success95% CI: [20.7, 54.3]
Comparison: ICU stay ≥ 4 days (No): Success95% CI: [50.5, 99.5]
Comparison: Mechanical ventilation (Yes): Success95% CI: [22.7, 56.1]
Comparison: Mechanical ventilation (No): Success95% CI: [46.4, 99]
Comparison: Antibiotics (Yes): Success95% CI: [33, 64.4]
Comparison: Antibiotics (No): Success95% CI: [0, 82.9]
Comparison: CV Catheter (Yes): Success95% CI: [31.5, 63.2]
Comparison: CV Catheter (No): Success95% CI: [10, 90]
Comparison: TPN (Yes): Success95% CI: [12, 64.9]
Comparison: TPN (No): Success95% CI: [34, 69.2]
Comparison: Dialysis (Yes): Success95% CI: [0, 40.2]
Comparison: Dialysis (No): Success95% CI: [38, 70.1]
Comparison: Abdominal surgery (Yes): Success95% CI: [19.9, 64.3]
Comparison: Abdominal surgery (No): Success95% CI: [32.4, 71.6]
Comparison: Solid organ transplant (No): Success95% CI: [33, 62.5]
Comparison: Renal insufficiency (Yes): Success95% CI: [0, 40.2]
Comparison: Renal insufficiency (No): Success95% CI: [38, 70.1]
Comparison: Chemotherapy (No): Success95% CI: [31.6, 61.4]
Comparison: Pancreatitis (Yes): Success95% CI: [0, 82.9]
Comparison: Pancreatitis (No): Success95% CI: [33, 64.4]
Comparison: Systemic steroids/immunos (Yes): Success95% CI: [13.8, 69.6]
Comparison: Systemic steroids/immunos (No): Success95% CI: [32.7, 67.3]
Comparison: Neutropenic: Success95% CI: [13.3, 100]
Comparison: Non-neutropenic: Success95% CI: [33.5, 69.9]
Secondary
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)
Population: MITT. Global Success if both clinical and microbiological response=success; Failure=all other combinations. Missing or indeterminate set to Failure; CI not calculated for failure. Due to small sample size, data was insufficient for analysis by status=elderly (\>65 years of age); not summarized.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | ICU stay ≥ 4 days (Yes): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | ICU stay ≥ 4 days (No): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | ICU stay ≥ 4 days (No): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Mechanical ventilation (Yes): Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Mechanical ventilation (No): Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Antibiotics (Yes): Failure | 17 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Antibiotics (No): Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | CV Catheter (Yes): Success | 21 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Abdominal surgery (Yes): Failure | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Pancreatitis (Yes): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | ICU stay ≥ 4 days (Yes): Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Antibiotics (Yes): Success | 22 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Mechanical ventilation (Yes): Failure | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Mechanical ventilation (No): Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | CV Catheter (No): Success | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | CV Catheter (No): Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | TPN (Yes): Success | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | TPN (Yes): Failure | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | TPN (No): Success | 21 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | TPN (No): Failure | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Dialysis (Yes): Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Dialysis (Yes): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Dialysis (No): Success | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Dialysis (No): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Abdominal surgery (Yes): Success | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Abdominal surgery (No): Success | 15 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Abdominal surgery (No): Failure | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Solid organ transplant (No): Success | 26 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Solid organ transplant (No): Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Renal insufficiency (Yes): Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Renal insufficiency (Yes): Failure | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Renal insufficiency (No): Success | 23 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Renal insufficiency (No): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Chemotherapy (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Chemotherapy (Yes): Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Chemotherapy (No): Success | 25 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Chemotherapy (No): Failure | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Pancreatitis (Yes): Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Pancreatitis (No): Success | 25 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Pancreatitis (No): Failure | 14 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Systemic steroids/immunos (Yes): Success | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Systemic steroids/immunos (Yes): Failure | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Systemic steroids/immunos (No): Success | 20 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Systemic steroids/immunos (No): Failure | 12 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Neutropenic: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Neutropenic: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Non-neutropenic: Success | 18 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Non-neutropenic: Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | Antibiotics (No): Success | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response for Pre-specified Baseline Risk Factors Subgroups of Interest: EOT | CV Catheter (Yes): Failure | 17 participants |
Comparison: ICU stay ≥ 4 days (Yes): Success95% CI: [39.1, 73.4]
Comparison: ICU stay ≥ 4 days (No): Success95% CI: [40, 93.3]
Comparison: Mechanical ventilation (Yes): Success95% CI: [37.6, 71.5]
Comparison: Mechanical ventilation (No): Success95% CI: [46.4, 99]
Comparison: Antibiotics (Yes): Success95% CI: [40.8, 72]
Comparison: Antibiotics (No): Success95% CI: [44.9, 100]
Comparison: CV Catheter (Yes): Success95% CI: [39.5, 71.1]
Comparison: CV Catheter (No): Success95% CI: [53.5, 100]
Comparison: TPN (Yes): Success95% CI: [12, 64.9]
Comparison: TPN (No): Success95% CI: [51.3, 84.2]
Comparison: Dialysis (Yes): Success95% CI: [6.2, 79.5]
Comparison: Dialysis (No): Success95% CI: [46.5, 77.8]
Comparison: Abdominal surgery (Yes): Success95% CI: [35.7, 80.1]
Comparison: Abdominal surgery (No): Success95% CI: [40.8, 79.2]
Comparison: Solid organ transplant (No): Success95% CI: [44.6, 73.6]
Comparison: Renal insufficiency (Yes): Success95% CI: [6.2, 79.5]
Comparison: Renal insufficiency (No): Success95% CI: [46.5, 77.8]
Comparison: Chemotherapy (No): Success95% CI: [43.4, 72.9]
Comparison: Pancreatitis (Yes): Success95% CI: [0, 55.1]
Comparison: Pancreatitis (No): Success95% CI: [49, 79.2]
Comparison: Systemic steroids/immunos (Yes): Success95% CI: [21.7, 78.3]
Comparison: Systemic steroids/immunos (No): Success95% CI: [45.7, 79.3]
Comparison: Neutropenic: Success95% CI: [13.3, 100]
Comparison: Non-neutropenic: Success95% CI: [44.4, 79.7]
Secondary
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)
Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida tropicalis: Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida albicans: Success | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida albicans: Failure | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida famata: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida famata: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida glabrata: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida glabrata: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida guilliermondii: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida guilliermondii: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida krusei: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida krusei: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida parapsilosis: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida parapsilosis: Failure | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida pelliculosa: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida pelliculosa: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Candida tropicalis: Failure | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Unidentifiable: Success | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EIVT | Unidentifiable: Failure | 3 participants |
Comparison: Candida tropicalis: Success95% CI: [55.2, 100]
Comparison: Unidentifiable: Success95% CI: [20.5, 93.8]
Comparison: Candida albicans: Success95% CI: [31, 73.7]
Comparison: Candida famata: Success95% CI: [0, 100]
Comparison: Candida glabrata: Success95% CI: [13.3, 100]
Comparison: Candida krusei: Success95% CI: [13.3, 100]
Comparison: Candida parapsilosis: Success95% CI: [0, 46.5]
Secondary
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)
Population: MITT. Missing or indeterminate set to Failure; CI not calculated for Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida albicans: Success | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida albicans: Failure | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida famata: Success | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida famata: Failure | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida glabrata: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida glabrata: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida guilliermondii: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida guilliermondii: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida krusei: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida krusei: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida parapsilosis: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida parapsilosis: Failure | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida pelliculosa: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida pelliculosa: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida tropicalis: Success | 8 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Candida tropicalis: Failure | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Unidentifiable: Success | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: EOT | Unidentifiable: Failure | 3 participants |
Comparison: Candida albicans: Success95% CI: [31, 73.7]
Comparison: Candida glabrata: Success95% CI: [13.3, 100]
Comparison: Candida krusei: Success95% CI: [13.3, 100]
Comparison: Candida parapsilosis: Success95% CI: [0, 46.5]
Comparison: Candida tropicalis: Success95% CI: [55.2, 100]
Comparison: Unidentifiable: Success95% CI: [20.5, 93.8]
Secondary
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
Population: MITT. Missing or indeterminate set to Failure; CI was not calculated for status of Failure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida parapsilosis: Success | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida famata: Failure | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida glabrata: Success | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida glabrata: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida guilliermondii: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida guilliermondii: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida krusei: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida krusei: Failure | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida parapsilosis: Failure | 6 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida pelliculosa: Success | 1 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida pelliculosa: Failure | 0 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida tropicalis: Success | 7 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida tropicalis: Failure | 3 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Unidentifiable: Success | 2 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Unidentifiable: Failure | 5 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida albicans: Success | 10 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida albicans: Failure | 11 participants |
| Anidulafungin-Voriconazole | Number of Participants for Global Response Per Type of Candida Species Isolated at Baseline: Week 2 Follow-up | Candida famata: Success | 0 participants |
Comparison: Candida albicans: Success95% CI: [26.3, 69]
Comparison: Candida krusei: Success95% CI: [13.3, 100]
Comparison: Candida tropicalis: Success95% CI: [41.6, 98.4]
Comparison: Unidentifiable: Success95% CI: [0, 62]
Secondary
Number of Participants Per Survival Status (Alive or Dead) on Day 30
Time frame: Day 30
Population: MITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants Per Survival Status (Alive or Dead) on Day 30 | Alive | 25 participants |
| Anidulafungin-Voriconazole | Number of Participants Per Survival Status (Alive or Dead) on Day 30 | Dead | 19 participants |
Secondary
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
Population: MITT. MITT. Death for 1 participant reported twice in this study(recorded at End of Treatment and at End of Study); both instances are reported in this table under Attributal Death=No.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin-Voriconazole | Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis | Attributable death (Yes) | 4 participants |
| Anidulafungin-Voriconazole | Number of Participants With Death Attributable (Yes or No) to Candidemia or Invasive Candidiasis | Attributable death (No) | 19 participants |
Secondary
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
Population: MITT; data not summarized using descriptive statistics.