Candidiasis, Fungemia, Neutropenia
Conditions
Keywords
Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia
Brief summary
The purpose of this study is to gather information on the use of anidulafungin for the treatment of Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.
Interventions
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dysfunctional immune system (reduced neutrophils). * Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection. * Male of female ≥16 years of age. * Expected hospitalization for at least ten (10) days.
Exclusion criteria
* Pregnancy or breast feeding or planning to become pregnant during the study. * Recent treatment with one of the study drugs over the last 30 days. * Allergy to either study drug or to this class of drugs. * Significant liver dysfunction. * Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Response at End of Intravenous Treatment (EOIVT) | Day 10 up to Day 42 | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Response at 2-Week Follow-Up Visit | 2 weeks post treatment | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Global Response at 6-Week Follow-Up Visit | 6 weeks post treatment | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Response Based on Clinical Cure and Microbiological Success at EOIVT | Day 10 up to Day 42 | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Response Based on Clinical Cure and Microbiological Success at EOT | Day 14 up to Day 56 | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 2 weeks post treatment | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 6 weeks post treatment | Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]). |
| Global Response at End of Treatment (EOT) | Day 14 up to Day 56 | Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse). |
| Number of Participants With Recurrence | 2 and 6 weeks post treatment | Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed. |
| Number of Participants With New Infections | 2 and 6 weeks post treatment | Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. |
| Time to First Negative Blood Culture for Candida Species | Baseline up to Day 56 | A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1. |
| Time to Death | Day 1 up to Day 98 | Time to death defined as: date of death minus first treatment date plus 1. |
| All-Cause Mortality | Baseline up to 6 weeks post treatment | All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up |
| Clinical Response at Day 10 | Day 10 | Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate. |
Countries
Bosnia and Herzegovina, France, Italy, Poland, Russia, Slovakia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Anidulafungin Participants received anidulafungin (100 milligrams \[mg\]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. | 15 |
| Caspofungin Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy. | 6 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 4 |
Baseline characteristics
| Characteristic | Anidulafungin | Caspofungin | Total |
|---|---|---|---|
| Age, Customized 18 to 44 years | 2 participants | 2 participants | 4 participants |
| Age, Customized 45 to 64 years | 9 participants | 2 participants | 11 participants |
| Age, Customized greater than or equal to (≥) 65 years | 4 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 6 Participants | 3 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 3 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 15 | 5 / 6 |
| serious Total, serious adverse events | 5 / 15 | 4 / 6 |
Outcome results
Primary
Global Response at End of Intravenous Treatment (EOIVT)
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: Day 10 up to Day 42
Population: Modified Intent to Treat (MITT) Population: participants who received at least 1 dose of study medication and had positive culture for Candida sp isolated from cultures obtained from a normally sterile site within 96 hours prior to treatment initiation. A global response of failure at EOIVT was carried forward programmatically to subsequent visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Global Response at End of Intravenous Treatment (EOIVT) | Success | 8 participants |
| Anidulafungin | Global Response at End of Intravenous Treatment (EOIVT) | Failure | 3 participants |
| Anidulafungin | Global Response at End of Intravenous Treatment (EOIVT) | Indeterminate | 0 participants |
| Caspofungin | Global Response at End of Intravenous Treatment (EOIVT) | Success | 3 participants |
| Caspofungin | Global Response at End of Intravenous Treatment (EOIVT) | Failure | 0 participants |
| Caspofungin | Global Response at End of Intravenous Treatment (EOIVT) | Indeterminate | 0 participants |
Comparison: The 95 percent confidence interval (95% CI) was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.95% CI: [-80.9, 40.3]
Secondary
All-Cause Mortality
All-cause mortality during study therapy and at follow-up visits reported as unique deaths at EOIVT, end of oral treatment (EOT-oral), 2 Week Follow-Up and 6 Week Follow-Up
Time frame: Baseline up to 6 weeks post treatment
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | All-Cause Mortality | at 6 Week Follow-Up Visit | 2 participants |
| Anidulafungin | All-Cause Mortality | at 2 Week Follow-Up Visit | 1 participants |
| Anidulafungin | All-Cause Mortality | at EOIVT | 1 participants |
| Anidulafungin | All-Cause Mortality | at EOT - oral | 1 participants |
| Caspofungin | All-Cause Mortality | at EOT - oral | 0 participants |
| Caspofungin | All-Cause Mortality | at 6 Week Follow-Up Visit | 0 participants |
| Caspofungin | All-Cause Mortality | at EOIVT | 1 participants |
| Caspofungin | All-Cause Mortality | at 2 Week Follow-Up Visit | 3 participants |
Secondary
Clinical Response at Day 10
Participant counts of clinical response categorized as success, failure, or indeterminate. Success: no s/s of Candida (cure) or significant but incomplete resolution of s/s of Candida; no additional systemic or oral antifungal treatment required (improvement). Failure: worsening of s/s of the Candida infection. Indeterminate: evaluation could not be made due to withdrawal from study prior to assessment of cure or failure. Participants who received fewer than 3 doses of study medication were assigned a clinical efficacy response of indeterminate.
Time frame: Day 10
Population: MITT Population; Number of participants analyzed (N): participants with evaluable data
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Clinical Response at Day 10 | Success | 7 participants |
| Anidulafungin | Clinical Response at Day 10 | Failure | 0 participants |
| Anidulafungin | Clinical Response at Day 10 | Indeterminate | 2 participants |
| Caspofungin | Clinical Response at Day 10 | Success | 3 participants |
| Caspofungin | Clinical Response at Day 10 | Failure | 0 participants |
| Caspofungin | Clinical Response at Day 10 | Indeterminate | 0 participants |
Comparison: The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.95% CI: [-90.6, 31.9]
Secondary
Global Response at 2-Week Follow-Up Visit
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: 2 weeks post treatment
Population: MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Global Response at 2-Week Follow-Up Visit | Success | 6 participants |
| Anidulafungin | Global Response at 2-Week Follow-Up Visit | Failure | 3 participants |
| Anidulafungin | Global Response at 2-Week Follow-Up Visit | Indeterminate | 0 participants |
| Caspofungin | Global Response at 2-Week Follow-Up Visit | Success | 1 participants |
| Caspofungin | Global Response at 2-Week Follow-Up Visit | Failure | 0 participants |
| Caspofungin | Global Response at 2-Week Follow-Up Visit | Indeterminate | 0 participants |
Comparison: The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.95% CI: [-97.5, 63.9]
Secondary
Global Response at 6-Week Follow-Up Visit
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: 6 weeks post treatment
Population: MITT Population; subset of participants who, according to the investigator, completed therapy and participants with global response of failure at EOIVT or EOT. A global response of failure at the 2-week and 6-week visits carried forward programmatically to all subsequent visits. Number of participants analyzed (N): participants with evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Global Response at 6-Week Follow-Up Visit | Success | 5 participants |
| Anidulafungin | Global Response at 6-Week Follow-Up Visit | Failure | 4 participants |
| Anidulafungin | Global Response at 6-Week Follow-Up Visit | Indeterminate | 0 participants |
| Caspofungin | Global Response at 6-Week Follow-Up Visit | Success | 1 participants |
| Caspofungin | Global Response at 6-Week Follow-Up Visit | Failure | 0 participants |
| Caspofungin | Global Response at 6-Week Follow-Up Visit | Indeterminate | 0 participants |
Comparison: The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.95% CI: [-97.5, 55]
Secondary
Global Response at End of Treatment (EOT)
Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no s/s of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (f/u culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (≥3 doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent (positive culture any Candida sp), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).
Time frame: Day 14 up to Day 56
Population: MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Global Response at End of Treatment (EOT) | Success | 8 participants |
| Anidulafungin | Global Response at End of Treatment (EOT) | Failure | 3 participants |
| Anidulafungin | Global Response at End of Treatment (EOT) | Indeterminate | 0 participants |
| Caspofungin | Global Response at End of Treatment (EOT) | Success | 3 participants |
| Caspofungin | Global Response at End of Treatment (EOT) | Failure | 0 participants |
| Caspofungin | Global Response at End of Treatment (EOT) | Indeterminate | 0 participants |
Comparison: The 95% CI was calculated using the method of exact unconditional confidence limits for the difference. Global response (rates of success) by using a 2-sided 95% CI for the true difference in efficacy (Anidulafungin minus Caspofungin) was calculated. Statistical testing was done at 2.5% alpha.95% CI: [-80.9, 40.3]
Secondary
Number of Participants With New Infections
Participant counts of microbiologic response of new infection defined as clinical failure with emergence of new Candida sp not identified at baseline at the original site of infection or at a distant site of infection. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida.
Time frame: 2 and 6 weeks post treatment
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Number of Participants With New Infections | 2 weeks post treatment | 0 participants |
| Anidulafungin | Number of Participants With New Infections | 6 weeks post treatment | 0 participants |
| Caspofungin | Number of Participants With New Infections | 2 weeks post treatment | 0 participants |
| Caspofungin | Number of Participants With New Infections | 6 weeks post treatment | 0 participants |
Secondary
Number of Participants With Recurrence
Participant counts of microbiologic response of recurrence defined as any baseline Candida sp isolated following eradication, or culture data were not available for participants with a clinical response of failure after a previous response of success. Clinical failure defined as ≥3 doses study medication and no significant improvement of s/s or death due to Candida. Clinical success is resolution of s/s and no additional antifungal treatment needed.
Time frame: 2 and 6 weeks post treatment
Population: MITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Anidulafungin | Number of Participants With Recurrence | 2 Weeks post treatment | 0 participants |
| Anidulafungin | Number of Participants With Recurrence | 6 Weeks post treatment | 0 participants |
| Caspofungin | Number of Participants With Recurrence | 2 Weeks post treatment | 0 participants |
| Caspofungin | Number of Participants With Recurrence | 6 Weeks post treatment | 0 participants |
Secondary
Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: 2 weeks post treatment
Population: MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 4 participants |
| Caspofungin | Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit | 1 participants |
Secondary
Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: 6 weeks post treatment
Population: MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication; Number of participants analyzed (N): participants with evaluable data a specified time point
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 6 participants |
| Caspofungin | Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit | 1 participants |
Secondary
Response Based on Clinical Cure and Microbiological Success at EOIVT
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: Day 10 up to Day 42
Population: MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOIVT was carried forward programmatically to all subsequent visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Response Based on Clinical Cure and Microbiological Success at EOIVT | 7 participants |
| Caspofungin | Response Based on Clinical Cure and Microbiological Success at EOIVT | 2 participants |
Secondary
Response Based on Clinical Cure and Microbiological Success at EOT
Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).
Time frame: Day 14 up to Day 56
Population: MITT Population; subset of participants with clinical cure or improvement and microbiological eradication or presumed eradication. A global response of failure at EOT was carried forward programmatically to all subsequent visits.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anidulafungin | Response Based on Clinical Cure and Microbiological Success at EOT | 6 participants |
| Caspofungin | Response Based on Clinical Cure and Microbiological Success at EOT | 3 participants |
Secondary
Time to Death
Time to death defined as: date of death minus first treatment date plus 1.
Time frame: Day 1 up to Day 98
Population: Safety Population;subset of participants who died
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anidulafungin | Time to Death | 34.0 days |
| Caspofungin | Time to Death | 15.5 days |
Secondary
Time to First Negative Blood Culture for Candida Species
A participant had a negative blood culture, if having determined the day of the first negative blood culture, the subsequent blood culture was also negative, or if positive, the interval between the cultures was at least 2 days. For participants whose blood culture went from positive to negative, the time to negative blood culture defined as: date of first negative blood culture minus first treatment date plus 1.
Time frame: Baseline up to Day 56
Population: MITT Population; subset of participants who had a positive blood culture for Candida sp. on Day 1 of treatment. No participant in the Caspofungin treatment arm had a positive blood culture for Candida sp. on Day 1 of treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Anidulafungin | Time to First Negative Blood Culture for Candida Species | 2.0 days |