Trial Outcomes & Findings for CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension (NCT NCT02734862)

Last Updated: 2020-12-08

Results Overview

Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

207 participants

Primary outcome timeframe

From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

Results posted on

2020-12-08

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Part A STARTED	35	36	36
Part A COMPLETED	23	28	22
Part A NOT COMPLETED	12	8	14
Part B STARTED	46	21	33
Part B COMPLETED	33	14	28
Part B NOT COMPLETED	13	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Part A Death	3	4	6
Part A Lost to Follow-up	2	1	1
Part A Withdrawal by Subject	1	1	2
Part A Physician Decision	2	0	1
Part A Adverse Event	2	0	1
Part A Noncompliance	1	1	0
Part A Other	1	1	3
Part B Death	8	3	5
Part B Lost to Follow-up	2	2	0
Part B Withdrawal by Subject	3	1	0
Part B Other	0	1	0

Baseline Characteristics

Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=81 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=57 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=69 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline	Total n=207 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=81 Participants	0 Participants n=57 Participants	0 Participants n=69 Participants	0 Participants n=207 Participants
Age, Categorical Between 18 and 65 years	49 Participants n=81 Participants	32 Participants n=57 Participants	40 Participants n=69 Participants	121 Participants n=207 Participants
Age, Categorical >=65 years	32 Participants n=81 Participants	25 Participants n=57 Participants	29 Participants n=69 Participants	86 Participants n=207 Participants
Age, Continuous	61.0 years n=81 Participants	63.0 years n=57 Participants	63.0 years n=69 Participants	62.0 years n=207 Participants
Sex: Female, Male Female	37 Participants n=81 Participants	21 Participants n=57 Participants	31 Participants n=69 Participants	89 Participants n=207 Participants
Sex: Female, Male Male	44 Participants n=81 Participants	36 Participants n=57 Participants	38 Participants n=69 Participants	118 Participants n=207 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=81 Participants	9 Participants n=57 Participants	7 Participants n=69 Participants	24 Participants n=207 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	73 Participants n=81 Participants	46 Participants n=57 Participants	59 Participants n=69 Participants	178 Participants n=207 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=81 Participants	2 Participants n=57 Participants	3 Participants n=69 Participants	5 Participants n=207 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=81 Participants	0 Participants n=57 Participants	0 Participants n=69 Participants	0 Participants n=207 Participants
Race (NIH/OMB) Asian	0 Participants n=81 Participants	1 Participants n=57 Participants	3 Participants n=69 Participants	4 Participants n=207 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=81 Participants	0 Participants n=57 Participants	0 Participants n=69 Participants	0 Participants n=207 Participants
Race (NIH/OMB) Black or African American	8 Participants n=81 Participants	7 Participants n=57 Participants	4 Participants n=69 Participants	19 Participants n=207 Participants
Race (NIH/OMB) White	69 Participants n=81 Participants	44 Participants n=57 Participants	59 Participants n=69 Participants	172 Participants n=207 Participants
Race (NIH/OMB) More than one race	0 Participants n=81 Participants	0 Participants n=57 Participants	0 Participants n=69 Participants	0 Participants n=207 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=81 Participants	5 Participants n=57 Participants	3 Participants n=69 Participants	12 Participants n=207 Participants
Region of Enrollment Greece	6 participants n=81 Participants	6 participants n=57 Participants	8 participants n=69 Participants	20 participants n=207 Participants
Region of Enrollment Canada	1 participants n=81 Participants	1 participants n=57 Participants	3 participants n=69 Participants	5 participants n=207 Participants
Region of Enrollment Romania	2 participants n=81 Participants	0 participants n=57 Participants	3 participants n=69 Participants	5 participants n=207 Participants
Region of Enrollment Belgium	9 participants n=81 Participants	9 participants n=57 Participants	12 participants n=69 Participants	30 participants n=207 Participants
Region of Enrollment Hungary	2 participants n=81 Participants	0 participants n=57 Participants	0 participants n=69 Participants	2 participants n=207 Participants
Region of Enrollment United States	26 participants n=81 Participants	22 participants n=57 Participants	23 participants n=69 Participants	71 participants n=207 Participants
Region of Enrollment Italy	7 participants n=81 Participants	2 participants n=57 Participants	5 participants n=69 Participants	14 participants n=207 Participants
Region of Enrollment Bulgaria	4 participants n=81 Participants	1 participants n=57 Participants	2 participants n=69 Participants	7 participants n=207 Participants
Region of Enrollment Russia	2 participants n=81 Participants	1 participants n=57 Participants	0 participants n=69 Participants	3 participants n=207 Participants
Region of Enrollment Spain	22 participants n=81 Participants	15 participants n=57 Participants	13 participants n=69 Participants	50 participants n=207 Participants
Diagnosis Candidemia	62 Participants n=81 Participants	46 Participants n=57 Participants	56 Participants n=69 Participants	164 Participants n=207 Participants
Diagnosis Invasive Candidiasis	19 Participants n=81 Participants	11 Participants n=57 Participants	13 Participants n=69 Participants	43 Participants n=207 Participants
Estimated Normalized Creatinine Clearance	81.8 mL/min/1.73m^2 n=79 Participants • Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance.	57.7 mL/min/1.73m^2 n=50 Participants • Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance.	74.4 mL/min/1.73m^2 n=64 Participants • Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance.	74.8 mL/min/1.73m^2 n=193 Participants • Data was not captured at baseline for all subjects, preventing calculation of the normalized creatinine clearance.
Acute Physiology and Chronic Health Evaluation (APACHE) II Score	12.0 units on a scale n=79 Participants • Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed.	14.0 units on a scale n=55 Participants • Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed.	13.0 units on a scale n=63 Participants • Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed.	12.0 units on a scale n=197 Participants • Data was not captured for all subjects, as some subjects did not have the APACHE II calculation performed.
Acute Physiology and Chronic Health Evaluation (APACHE) II Category 0-9	23 Participants n=81 Participants	15 Participants n=57 Participants	17 Participants n=69 Participants	55 Participants n=207 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) II Category 10-19	39 Participants n=81 Participants	26 Participants n=57 Participants	37 Participants n=69 Participants	102 Participants n=207 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) II Category ≥20	17 Participants n=81 Participants	14 Participants n=57 Participants	9 Participants n=69 Participants	40 Participants n=207 Participants
Acute Physiology and Chronic Health Evaluation (APACHE) II Category Missing	2 Participants n=81 Participants	2 Participants n=57 Participants	6 Participants n=69 Participants	10 Participants n=207 Participants

PRIMARY outcome

Timeframe: From first dose of study drug through Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

Population: Safety Population includes all subjects randomized to treatment and who received any amount of study drug. A total of 202 subjects were included in the Safety Population.

Number of Subjects with Incidence of Treatment Emergent Adverse Events based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and ECG abnormalities.

Outcome measures

Outcome measures
Measure	Group 1 n=81 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=53 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=68 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	71 Participants	49 Participants	55 Participants

PRIMARY outcome

Timeframe: Day 14 (± 1 day)

Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline

Outcome measures

Outcome measures
Measure	Group 1 n=76 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=46 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=61 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]	46 Participants	35 Participants	41 Participants

SECONDARY outcome

Timeframe: Day 5, and Follow-up (FU Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia.

Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.

Outcome measures

Outcome measures
Measure	Group 1 n=76 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=46 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=61 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Mycological Eradication and Resolution of Systemic Signs Day 5	42 Participants	34 Participants	34 Participants
Mycological Eradication and Resolution of Systemic Signs Follow-up	36 Participants	30 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 5, Day 14 (±1 day), and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia)

Evaluate mycological success (eradication) in the mITT population.

Outcome measures

Outcome measures
Measure	Group 1 n=76 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=46 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=61 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Mycological Eradication Day 5	50 Participants	35 Participants	38 Participants
Mycological Eradication Day 14	50 Participants	35 Participants	42 Participants
Mycological Eradication Follow-up	39 Participants	30 Participants	36 Participants

SECONDARY outcome

Timeframe: Day 14 (±1 day) and FU (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia).

Evaluate clinical cure as assessed by the Investigator in the mITT population. Subjects must meet all of the following requirements: * Resolution of attributable systemic signs and symptoms of candidemia/IC that were present at baseline * No new systemic signs or symptoms attributable to candidemia/IC * No additional systemic antifungal therapy administered for candidemia/IC * The subject is alive

Outcome measures

Outcome measures
Measure	Group 1 n=76 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=46 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=61 Participants Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Clinical Cure Follow-up	42 Participants	32 Participants	38 Participants
Clinical Cure Day 14	53 Participants	37 Participants	43 Participants

SECONDARY outcome

Timeframe: Day 1, 10 minutes before end of infusion (EOI)

Population: PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.

Evaluate maximum plasma concentration (Cmax) (Part A only)

Outcome measures

Outcome measures
Measure	Group 1 n=29 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=30 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Evaluate PK (Cmax)	15.258 μg/mL Standard Deviation 5.5430	14.743 μg/mL Standard Deviation 5.6450	—

SECONDARY outcome

Timeframe: Day 8, predose

Population: PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.

Evaluate minimum plasma concentration (Cmin) (Part A only)

Outcome measures

Outcome measures
Measure	Group 1 n=25 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=28 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Evaluate PK (Cmin)	2.050 μg/mL Standard Deviation 0.9767	2.313 μg/mL Standard Deviation 1.2165	—

SECONDARY outcome

Timeframe: Day 15, predose

Population: PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis.

Evaluate minimum plasma concentration (Cmin) (Part A only)

Outcome measures

Outcome measures
Measure	Group 1 n=21 Participants Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=21 Participants Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Evaluate PK (Cmin)	3.068 μg/mL Standard Deviation 1.4565	2.131 μg/mL Standard Deviation 0.8506	—

Adverse Events

Group 1

Serious events: 35 serious events

Other events: 70 other events

Deaths: 14 deaths

Group 2

Serious events: 28 serious events

Other events: 49 other events

Deaths: 7 deaths

Group 3

Serious events: 29 serious events

Other events: 53 other events

Deaths: 13 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1 n=81 participants at risk Subjects in the CD101 IV treatment group 1 (Part A Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 400 mg on Day 15 (for all subjects) and an optional dose of 400 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 2 n=53 participants at risk Subjects in the CD101 IV treatment group 2 (Part B Only - up to 30 mITT subjects) will receive CD101 IV 400 mg on Day 1 and Day 8, with an optional dose of 200 mg on Day 15 (for all subjects) and an optional dose of 200 mg on Day 22 (only for subjects with IC), if needed. Daily intravenous placebo infusion when not administered CD101. Daily oral placebo as step down. CD101: Intravenous antifungal therapy intravenous placebo: normal saline oral placebo: microcrystalline cellulose	Group 3 n=68 participants at risk Subjects in the caspofungin group will receive IV caspofungin (a single 70 mg loading dose on Day 1 followed by 50 mg once daily) for ≥3 days up to a maximum of 21 days for subjects with candidemia only and up to a maximum of 28 days for subjects with IC (with or without candidemia). After ≥3 days of IV therapy, subjects in the caspofungin group can be switched to oral step-down therapy of fluconazole (a loading dose of 800 mg \[4 capsules\] on the first day followed by 400 mg \[2 capsules\]/day thereafter). After switch to oral step down before Day 8, subjects in the caspofungin group will receive IV placebo on Day 8 to preserve the study blind. Caspofungin: Intravenous antifungal therapy Fluconazole: oral antifungal therapy intravenous placebo: normal saline
Metabolism and nutrition disorders Hypokalaemia	16.0% 13/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	17.0% 9/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	13.2% 9/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Diarrhoea	8.6% 7/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	20.8% 11/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	14.7% 10/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Vomiting	7.4% 6/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	15.1% 8/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	7.4% 5/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
General disorders Pyrexia	11.1% 9/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	7.5% 4/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	8.8% 6/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Blood and lymphatic system disorders Anaemia	7.4% 6/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	13.2% 7/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	5.9% 4/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Nausea	4.9% 4/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	15.1% 8/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	8.8% 6/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Gastrointestinal disorders Abdominal pain	6.2% 5/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	9.4% 5/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	5.9% 4/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Vascular disorders Hypotension	7.4% 6/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	3.8% 2/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	5.9% 4/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Psychiatric disorders Insomnia	4.9% 4/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	7.5% 4/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	2.9% 2/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
General disorders Oedema peripheral	7.4% 6/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	3.8% 2/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	0.00% 0/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.
Skin and subcutaneous tissue disorders Decubitus ulcer	4.9% 4/81 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	5.7% 3/53 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.	4.4% 3/68 • Adverse events were collected following the signing of the informed consent at screening and throughout the study until the follow up visit (Days 45-52 for subjects with candidemia only or Days 52-59 for subjects with IC, with or without candidemia). All-Cause Mortality was assessed in the Intent-to-Treat (ITT) Population. The ITT Population consisted of all subjects randomized to treatment. Serious and Other Adverse Events were assessed in the Safety Population. The Safety Population consisted of all subjects randomized who received any amount of study drug. All safety analyses were performed by actual treatment received.

Additional Information

Taylor Sandison, M.D., MPH

Cidara Therapeutics, Inc.

Phone: 858-888-7868

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER