Trial Outcomes & Findings for An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System (NCT NCT00806351)

Last Updated: 2012-12-20

Results Overview

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).

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

21 participants

Primary outcome timeframe

Day 10 up to Day 42

Results posted on

2012-12-20

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	15	6
Overall Study COMPLETED	10	2
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Overall Study Death	5	4

Baseline Characteristics

An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Anidulafungin n=15 Participants 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.	Caspofungin n=6 Participants 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.	Total n=21 Participants Total of all reporting groups
Age, Customized 18 to 44 years	2 participants n=5 Participants	2 participants n=7 Participants	4 participants n=5 Participants
Age, Customized 45 to 64 years	9 participants n=5 Participants	2 participants n=7 Participants	11 participants n=5 Participants
Age, Customized greater than or equal to (≥) 65 years	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=11 Participants 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.	Caspofungin n=3 Participants 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.
Global Response at End of Intravenous Treatment (EOIVT) Success	8 participants	3 participants
Global Response at End of Intravenous Treatment (EOIVT) Failure	3 participants	0 participants
Global Response at End of Intravenous Treatment (EOIVT) Indeterminate	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 14 up to Day 56

Population: MITT Population; A global response of failure at EOT was carried forward programmatically to all subsequent visits.

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).

Outcome measures

Outcome measures
Measure	Anidulafungin n=11 Participants 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.	Caspofungin n=3 Participants 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.
Global Response at End of Treatment (EOT) Success	8 participants	3 participants
Global Response at End of Treatment (EOT) Failure	3 participants	0 participants
Global Response at End of Treatment (EOT) Indeterminate	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=9 Participants 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.	Caspofungin n=1 Participants 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.
Global Response at 2-Week Follow-Up Visit Success	6 participants	1 participants
Global Response at 2-Week Follow-Up Visit Failure	3 participants	0 participants
Global Response at 2-Week Follow-Up Visit Indeterminate	0 participants	0 participants

SECONDARY outcome

Timeframe: 6 weeks post treatment

Outcome measures

Outcome measures
Measure	Anidulafungin n=9 Participants 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.	Caspofungin n=1 Participants 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.
Global Response at 6-Week Follow-Up Visit Success	5 participants	1 participants
Global Response at 6-Week Follow-Up Visit Failure	4 participants	0 participants
Global Response at 6-Week Follow-Up Visit Indeterminate	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

Participant counts of clinical cure (no s/s of Candida) and microbiological success (eradication \[f/u culture negative\] or presumed eradication \[f/u culture not available and a clinical response of cure\]).

Outcome measures

Outcome measures
Measure	Anidulafungin n=8 Participants 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.	Caspofungin n=3 Participants 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.
Response Based on Clinical Cure and Microbiological Success at EOIVT	7 participants	2 participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=8 Participants 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.	Caspofungin n=3 Participants 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.
Response Based on Clinical Cure and Microbiological Success at EOT	6 participants	3 participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Anidulafungin n=6 Participants 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.	Caspofungin n=1 Participants 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.
Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit	4 participants	1 participants

SECONDARY outcome

Timeframe: 6 weeks post treatment

Outcome measures

Outcome measures
Measure	Anidulafungin n=6 Participants 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.	Caspofungin n=1 Participants 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.
Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit	6 participants	1 participants

SECONDARY outcome

Timeframe: Day 10

Population: MITT Population; Number of participants analyzed (N): participants with evaluable data

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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=9 Participants 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.	Caspofungin n=3 Participants 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.
Clinical Response at Day 10 Success	7 participants	3 participants
Clinical Response at Day 10 Failure	0 participants	0 participants
Clinical Response at Day 10 Indeterminate	2 participants	0 participants

SECONDARY outcome

Timeframe: 2 and 6 weeks post treatment

Population: MITT Population

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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=11 Participants 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.	Caspofungin n=3 Participants 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.
Number of Participants With Recurrence 2 Weeks post treatment	0 participants	0 participants
Number of Participants With Recurrence 6 Weeks post treatment	0 participants	0 participants

SECONDARY outcome

Timeframe: 2 and 6 weeks post treatment

Population: MITT Population

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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=11 Participants 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.	Caspofungin n=3 Participants 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.
Number of Participants With New Infections 2 weeks post treatment	0 participants	0 participants
Number of Participants With New Infections 6 weeks post treatment	0 participants	0 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Anidulafungin n=5 Participants 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.	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.
Time to First Negative Blood Culture for Candida Species	2.0 days Interval 2.0 to 5.0	—

SECONDARY outcome

Timeframe: Day 1 up to Day 98

Population: Safety Population;subset of participants who died

Time to death defined as: date of death minus first treatment date plus 1.

Outcome measures

Outcome measures
Measure	Anidulafungin n=5 Participants 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.	Caspofungin n=4 Participants 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.
Time to Death	34.0 days Interval 5.0 to 36.0	15.5 days Interval 3.0 to 41.0

SECONDARY outcome

Timeframe: Baseline up to 6 weeks post treatment

Population: Safety Population

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

Outcome measures

Outcome measures
Measure	Anidulafungin n=15 Participants 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.	Caspofungin n=6 Participants 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.
All-Cause Mortality at EOIVT	1 participants	1 participants
All-Cause Mortality at EOT - oral	1 participants	0 participants
All-Cause Mortality at 2 Week Follow-Up Visit	1 participants	3 participants
All-Cause Mortality at 6 Week Follow-Up Visit	2 participants	0 participants

Adverse Events

Anidulafungin

Serious events: 5 serious events

Other events: 14 other events

Deaths: 0 deaths

Caspofungin

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Anidulafungin n=15 participants at risk 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.	Caspofungin n=6 participants at risk 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.
General disorders Drug ineffective	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
General disorders Multi-organ failure	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Hepatobiliary disorders hepatotoxicity	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Candidiasis	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Pneumonia	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	33.3% 2/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Infections and infestations Septic shock	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukaemia	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	16.7% 1/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory distress	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.7% 1/15 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.	0.00% 0/6 All-causality events reported. The same event may appear as both an adverse event (AE) and serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER