STRIVE: CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if intravenous CD101 is safe and effective in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This Bridging Extension is to determine if intravenous CD101 is safe [Day 45- 52 for subjects with candidemia only, or Day 52- 59 for subjects with invasive candidiasis with or without candidemia] and effective [Day 14 (± 1 day)] in the treatment of candidemia and/or invasive candidiasis when compared to caspofungin (followed by oral fluconazole).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: 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. |
Drug: CD101
Intravenous antifungal therapy
Other Names:
Drug: intravenous placebo
normal saline
Other Names:
Drug: oral placebo
microcrystalline cellulose
Other Names:
|
Active Comparator: 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. |
Drug: Caspofungin
Intravenous antifungal therapy
Other Names:
Drug: Fluconazole
oral antifungal therapy
Other Names:
Drug: intravenous placebo
normal saline
Other Names:
|
Experimental: 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. |
Drug: CD101
Intravenous antifungal therapy
Other Names:
Drug: intravenous placebo
normal saline
Other Names:
Drug: oral placebo
microcrystalline cellulose
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] [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.]
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.
- Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] [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
Secondary Outcome Measures
- Mycological Eradication and Resolution of Systemic Signs [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.
- Mycological Eradication [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.
- Clinical Cure [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
- Evaluate PK (Cmax) [Day 1, 10 minutes before end of infusion (EOI)]
Evaluate maximum plasma concentration (Cmax) (Part A only)
- Evaluate PK (Cmin) [Day 8, predose]
Evaluate minimum plasma concentration (Cmin) (Part A only)
- Evaluate PK (Cmin) [Day 15, predose]
Evaluate minimum plasma concentration (Cmin) (Part A only)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
mycological diagnosis of candidemia and/or invasive candidiasis from a sample taken less than or equal to 96 hours before randomization (defined as: at least 1 blood culture positive for Candida or positive test for Candida from a sponsor approved rapid diagnostic test or positive gram stain for yeast or positive culture for Candida spp. from a specimen obtained from a normally sterile site)
-
willing to initiate or continue medical treatment to cure infections, including receipt of antibiotics and surgical procedures, if required. Patients receiving only medications and measures for comfort and not cure should not be enrolled.
-
female subjects of child bearing potential <2 years post menopausal must agree to one barrier method and one highly effective method of birth control or sexual abstinence.
-
male subjects must be vasectomized, abstain from sexual intercourse, or agree to use barrier contraception (condom with spermicide), and also agree not to donate sperm from first dose of CD101 (Day 1) until 90 days following last administration of study drug.
-
willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally acceptable representative must provide informed consent on their behalf.
-
presence of one or more systemic signs attributable to candidemia and/or invasive candidiasis
Exclusion Criteria:
- Any of the following forms of IC:
-
Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed)
-
Osteomyelitis
-
Endocarditis or myocarditis
-
Meningitis, endophthalmitis, or any central nervous system infection
-
neutropenia
-
alanine aminotransferase or aspartate aminotransferase levels >10 fold the upper limit of normal
-
severe hepatic impairment in subjects with a history of chronic cirrhosis
-
greater than 48 hours systemic antifungal treatment at approved doses to treat candidemia
-
pregnant females
-
lactating females who are nursing
-
known hypersensitivity to CD101, caspofungin, any echinocandin, or to any of their excipients
-
previous participation in this or any previous CD101 study
-
recent use of an investigational medicinal product within 28 days of first dose of study drug or presence of an investigational device at the time of screening
-
Principal Investigator considers the subject should not participate
-
presence of indwelling vascular catheter or device that cannot be removed and is likely to be the source of candidemia
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
2 | University of California - Davis | Davis | California | United States | 95817 |
3 | University of Miami Miller School of Medicine | Miami | Florida | United States | 33136 |
4 | Augusta University | Augusta | Georgia | United States | 30912 |
5 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
6 | Harper University Hospital | Detroit | Michigan | United States | 48201 |
7 | Henry Ford Health System | Detroit | Michigan | United States | 48202 |
8 | William Beaumont Hospital | Royal Oak | Michigan | United States | 48073 |
9 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
10 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
11 | Mercury Street Medical | Butte | Montana | United States | 59701 |
12 | Albany Medical Center | Albany | New York | United States | 12208 |
13 | Mercy Health - St. Vincent Medical Center - ID Clinical Research | Toledo | Ohio | United States | 43608 |
14 | Reading Hospital and Medical Center | West Reading | Pennsylvania | United States | 19611 |
15 | University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
16 | Virginia Tech, Carillion School of Medicine | Roanoke | Virginia | United States | 24016 |
17 | Jules Bordet Institute | Brussels | Belgium | 1000 | |
18 | CHU Brugman | Brussels | Belgium | 1020 | |
19 | Erasme Hospital | Brussels | Belgium | 1070 | |
20 | UCL Saint-LUC | Brussels | Belgium | 1200 | |
21 | UZ Gent Algemene Inwendige Zietken | Gent | Belgium | 9000 | |
22 | University Hospital Brussels | Jette | Belgium | 1090 | |
23 | University Hospital Leuven | Leuven | Belgium | 3000 | |
24 | CHU Sart-Tillman | Liège | Belgium | 4000 | |
25 | University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Sofia, Clinic of Clinical Hematology | Sofia | Bulgaria | 1431 | |
26 | University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Burns and Plastic Surgery Clinic, Department of Anesthesiology and Intensive Care | Sofia | Bulgaria | 1606 | |
27 | Juravinski Hospital and Cancer Centre/Hamilton Health Sciences | Hamilton | Ontario | Canada | L8V 1C3 |
28 | Toronto General Hospital-University Health Network | Toronto | Ontario | Canada | M5G 2N2 |
29 | CIUSSS de L'Est-de-l'Île-De-Montréal, Installation Hôpital | Montréal | Quebec | Canada | H1T 2M4 |
30 | McGill University Health Centre-Research Institute | Montréal | Quebec | Canada | H4A 3J1 |
31 | University General Hospital "Attikon", 2nd Department of Critical Care | Athens | Chaidari | Greece | 12 462 |
32 | General Hospital of Athens "Evangelismos", 5th Department of Internal Medicine and Infectious Diseases Unit | Athens | Greece | 10676 | |
33 | Laiko General Hospital of Athens | Athens | Greece | 115 27 | |
34 | Henry Dunant Hospital Center | Athens | Greece | 11526 | |
35 | General Hospital of Athens "Evangelismos", Department of Critical Care | Athens | Greece | ||
36 | University Hospital of Larissa, Department of Critical Care Unit | Thessaloníki | Greece | 41110 | |
37 | Medical Centre, Hungarian Defence Forces, Central Intensive Care Unit and Anesthesiology Department | Budapest | Hungary | 1134 | |
38 | Fejer County St. Gyorgy University Teaching Hospital, Central Department of Anesthesiology and Intensive Care Unit | Szeged | Hungary | 6725 | |
39 | Polyclinic S. Orsola-Malpighi, Department of Organ Impairment and Transplants, Operative Unit of Infectious Diseases | Bologna | Italy | 40138 | |
40 | University Polyclinic Hospital of Modena, Department of General and Specialist Surgery, Operative Unit of Anesthesia and Intensive Care I | Modena | Italy | 41124 | |
41 | University Hospital of Pisa, Department of Gastroenterology and Infectious Diseases, Operative Unit of Infectious Diseases | Pisa | Italy | 56124 | |
42 | University Polyclinic Agostino Gemelli, Complex Operative Unit of Infectious Diseases 2 | Rome | Italy | 00168 | |
43 | Hospital Maggiore University Hospital Ospedali Riuniti of Trieste Dept of ID | Trieste | Italy | 34125 | |
44 | University Hospital "Santa Maria della Misericordia" of Udine, Department of Specialist Medicine, Clinic of Infectious Diseases | Udine | Italy | 33100 | |
45 | Craiova County Emergency Clinical Hospital, ATI Clinic | Craiova | Dolj County | Romania | 200642 |
46 | Institute of Infectious Diseases | Bucharest | Sector 2 | Romania | 021105 |
47 | Pius Brinzeu County Emergency Clinical Hospital, Anesthesia and Intensive Care Department (Romania) | Timişoara | Timis County | Romania | 300723 |
48 | Sfanta Parascheva Parascheva Iasi Clinical Hospital for Infectious Diseases | Iaşi | Romania | 700116 | |
49 | Kuban State Medical University | Krasnodar | Russian Federation | 350063 | |
50 | Territorial Clinical Hospital | Krasnoyarsk | Russian Federation | 660022 | |
51 | Mariinskaya City Hospital | Saint Petersburg | Russian Federation | 191104 | |
52 | University Hospital Vall d'Hebron (HUVH), Department of Infectious Diseases | Barcelona | Catalonia | Spain | 08035 |
53 | Hospital Clinic i Provincial de Barcelona, Department of Infectious Diseases | Barcelona | Catalonia | Spain | 08036 |
54 | University Hospital Cruces, Unit of Infectious Diseases | Barakaldo | Spain | 48903 | |
55 | Hospital del Mar, Department of Infectious Diseases | Barcelona | Spain | 08003 | |
56 | General University Hospital Gregorio Maranon | Madrid | Spain | 28007 | |
57 | University Hospital Ramon y Cajal | Madrid | Spain | 28034 | |
58 | University Hospital Clinical San Carlos | Madrid | Spain | 28040 | |
59 | University Hospital La Paz | Madrid | Spain | 28046 | |
60 | University Hospital Virgen Macarena | Sevilla | Spain | 41009 | |
61 | University Hospital Nuestra Senora de Valme, | Sevilla | Spain | 41014 | |
62 | University Hospital Virgen del Rocio (HUVR) | Sevilla | Spain | ||
63 | University Hospital La Fe | Valencia | Spain | 46026 |
Sponsors and Collaborators
- Cidara Therapeutics Inc.
Investigators
- Study Director: Taylor Sandison, MD MPH, Cidara Therapeutics
Study Documents (Full-Text)
More Information
Publications
None provided.- CD101.IV.2.03
- 2015-005599-51
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Period Title: Part A | |||
STARTED | 35 | 36 | 36 |
COMPLETED | 23 | 28 | 22 |
NOT COMPLETED | 12 | 8 | 14 |
Period Title: Part A | |||
STARTED | 46 | 21 | 33 |
COMPLETED | 33 | 14 | 28 |
NOT COMPLETED | 13 | 7 | 5 |
Baseline Characteristics
Arm/Group Title | Group 1 | Group 2 | Group 3 | Total |
---|---|---|---|---|
Arm/Group Description | 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 | 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 | 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 of all reporting groups |
Overall Participants | 81 | 57 | 69 | 207 |
Age (Count of Participants) | ||||
<=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Between 18 and 65 years |
49
60.5%
|
32
56.1%
|
40
58%
|
121
58.5%
|
>=65 years |
32
39.5%
|
25
43.9%
|
29
42%
|
86
41.5%
|
Age (Years) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [Years] |
59.4
(15.86)
|
60.0
(15.90)
|
59.4
(15.85)
|
59.6
(15.79)
|
Age (years) [Median (Full Range) ] | ||||
Median (Full Range) [years] |
61.0
|
63.0
|
63.0
|
62.0
|
Sex: Female, Male (Count of Participants) | ||||
Female |
37
45.7%
|
21
36.8%
|
31
44.9%
|
89
43%
|
Male |
44
54.3%
|
36
63.2%
|
38
55.1%
|
118
57%
|
Ethnicity (NIH/OMB) (Count of Participants) | ||||
Hispanic or Latino |
8
9.9%
|
9
15.8%
|
7
10.1%
|
24
11.6%
|
Not Hispanic or Latino |
73
90.1%
|
46
80.7%
|
59
85.5%
|
178
86%
|
Unknown or Not Reported |
0
0%
|
2
3.5%
|
3
4.3%
|
5
2.4%
|
Race (NIH/OMB) (Count of Participants) | ||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
1
1.8%
|
3
4.3%
|
4
1.9%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
8
9.9%
|
7
12.3%
|
4
5.8%
|
19
9.2%
|
White |
69
85.2%
|
44
77.2%
|
59
85.5%
|
172
83.1%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
4
4.9%
|
5
8.8%
|
3
4.3%
|
12
5.8%
|
Region of Enrollment (participants) [Number] | ||||
Greece |
6
7.4%
|
6
10.5%
|
8
11.6%
|
20
9.7%
|
Canada |
1
1.2%
|
1
1.8%
|
3
4.3%
|
5
2.4%
|
Romania |
2
2.5%
|
0
0%
|
3
4.3%
|
5
2.4%
|
Belgium |
9
11.1%
|
9
15.8%
|
12
17.4%
|
30
14.5%
|
Hungary |
2
2.5%
|
0
0%
|
0
0%
|
2
1%
|
United States |
26
32.1%
|
22
38.6%
|
23
33.3%
|
71
34.3%
|
Italy |
7
8.6%
|
2
3.5%
|
5
7.2%
|
14
6.8%
|
Bulgaria |
4
4.9%
|
1
1.8%
|
2
2.9%
|
7
3.4%
|
Russia |
2
2.5%
|
1
1.8%
|
0
0%
|
3
1.4%
|
Spain |
22
27.2%
|
15
26.3%
|
13
18.8%
|
50
24.2%
|
Diagnosis (Count of Participants) | ||||
Candidemia |
62
76.5%
|
46
80.7%
|
56
81.2%
|
164
79.2%
|
Invasive Candidiasis |
19
23.5%
|
11
19.3%
|
13
18.8%
|
43
20.8%
|
Estimated Normalized Creatinine Clearance (mL/min/1.73m^2) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [mL/min/1.73m^2] |
90.8
(52.03)
|
72.8
(52.14)
|
87.1
(59.29)
|
84.9
(54.78)
|
Estimated Normalized Creatinine Clearance (mL/min/1.73m^2) [Median (Full Range) ] | ||||
Median (Full Range) [mL/min/1.73m^2] |
81.8
|
57.7
|
74.4
|
74.8
|
Acute Physiology and Chronic Health Evaluation (APACHE) II Score (units on a scale) [Mean (Standard Deviation) ] | ||||
Mean (Standard Deviation) [units on a scale] |
13.4
(7.13)
|
14.1
(6.72)
|
14.0
(7.39)
|
13.8
(7.07)
|
Acute Physiology and Chronic Health Evaluation (APACHE) II Score (units on a scale) [Median (Full Range) ] | ||||
Median (Full Range) [units on a scale] |
12.0
|
14.0
|
13.0
|
12.0
|
Acute Physiology and Chronic Health Evaluation (APACHE) II Category (Count of Participants) | ||||
0-9 |
23
28.4%
|
15
26.3%
|
17
24.6%
|
55
26.6%
|
10-19 |
39
48.1%
|
26
45.6%
|
37
53.6%
|
102
49.3%
|
≥20 |
17
21%
|
14
24.6%
|
9
13%
|
40
19.3%
|
Missing |
2
2.5%
|
2
3.5%
|
6
8.7%
|
10
4.8%
|
Outcome Measures
Title | Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] |
---|---|
Description | 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. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Measure Participants | 81 | 53 | 68 |
Count of Participants [Participants] |
71
87.7%
|
49
86%
|
55
79.7%
|
Title | Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] |
---|---|
Description | Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline |
Time Frame | Day 14 (± 1 day) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Measure Participants | 76 | 46 | 61 |
Count of Participants [Participants] |
46
56.8%
|
35
61.4%
|
41
59.4%
|
Title | Mycological Eradication and Resolution of Systemic Signs |
---|---|
Description | Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population. |
Time Frame | 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. |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Measure Participants | 76 | 46 | 61 |
Day 5 |
42
51.9%
|
34
59.6%
|
34
49.3%
|
Follow-up |
36
44.4%
|
30
52.6%
|
36
52.2%
|
Title | Mycological Eradication |
---|---|
Description | Evaluate mycological success (eradication) in the mITT population. |
Time Frame | 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) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Measure Participants | 76 | 46 | 61 |
Day 5 |
50
61.7%
|
35
61.4%
|
38
55.1%
|
Day 14 |
50
61.7%
|
35
61.4%
|
42
60.9%
|
Follow-up |
39
48.1%
|
30
52.6%
|
36
52.2%
|
Title | Clinical Cure |
---|---|
Description | 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 |
Time Frame | 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). |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Group 1 | Group 2 | Group 3 |
---|---|---|---|
Arm/Group Description | 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 | 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 | 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 |
Measure Participants | 76 | 46 | 61 |
Day 14 |
53
65.4%
|
37
64.9%
|
43
62.3%
|
Follow-up |
42
51.9%
|
32
56.1%
|
38
55.1%
|
Title | Evaluate PK (Cmax) |
---|---|
Description | Evaluate maximum plasma concentration (Cmax) (Part A only) |
Time Frame | Day 1, 10 minutes before end of infusion (EOI) |
Outcome Measure Data
Analysis Population Description |
---|
PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. |
Arm/Group Title | Group 1 | Group 2 |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 29 | 30 |
Mean (Standard Deviation) [μg/mL] |
15.258
(5.5430)
|
14.743
(5.6450)
|
Title | Evaluate PK (Cmin) |
---|---|
Description | Evaluate minimum plasma concentration (Cmin) (Part A only) |
Time Frame | Day 8, predose |
Outcome Measure Data
Analysis Population Description |
---|
PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. |
Arm/Group Title | Group 1 | Group 2 |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 25 | 28 |
Mean (Standard Deviation) [μg/mL] |
2.050
(0.9767)
|
2.313
(1.2165)
|
Title | Evaluate PK (Cmin) |
---|---|
Description | Evaluate minimum plasma concentration (Cmin) (Part A only) |
Time Frame | Day 15, predose |
Outcome Measure Data
Analysis Population Description |
---|
PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. |
Arm/Group Title | Group 1 | Group 2 |
---|---|---|
Arm/Group Description | 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 | 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 |
Measure Participants | 21 | 21 |
Mean (Standard Deviation) [μg/mL] |
3.068
(1.4565)
|
2.131
(0.8506)
|
Adverse Events
Time Frame | 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). | |||||
---|---|---|---|---|---|---|
Adverse Event Reporting Description | 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. | |||||
Arm/Group Title | Group 1 | Group 2 | Group 3 | |||
Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 14/81 (17.3%) | 7/57 (12.3%) | 13/69 (18.8%) | |||
Serious Adverse Events |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 35/81 (43.2%) | 28/53 (52.8%) | 29/68 (42.6%) | |||
Blood and lymphatic system disorders | ||||||
Disseminated intravascular coagulation | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Haemorrhagic anaemia | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Iron deficiency anaemia | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Sickle cell anaemia with crisis | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Cardiac disorders | ||||||
Angina pectoris | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Atrial flutter | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Atrioventricular block | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Bradycardia | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Cardiac arrest | 0/81 (0%) | 1/53 (1.9%) | 1/68 (1.5%) | |||
Cardiac failure | 0/81 (0%) | 1/53 (1.9%) | 1/68 (1.5%) | |||
Right ventricular failure | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Ventricular tachycardia | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Gastrointestinal disorders | ||||||
Abdominal pain | 0/81 (0%) | 1/53 (1.9%) | 1/68 (1.5%) | |||
Colonic fistula | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Gastrointestinal haemorrhage | 2/81 (2.5%) | 1/53 (1.9%) | 0/68 (0%) | |||
Haemorrhagic ascites | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Impaired gastric emptying | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Peritoneocutaneous fistula | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Rectal haemorrhage | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Upper gastrointestinal haemorrhage | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Vomiting | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
General disorders | ||||||
Generalised oedema | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Multiple organ dysfunction syndrome | 2/81 (2.5%) | 0/53 (0%) | 2/68 (2.9%) | |||
Hepatobiliary disorders | ||||||
Biloma | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Drug-induced liver injury | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Infections and infestations | ||||||
Abdominal abscess | 1/81 (1.2%) | 1/53 (1.9%) | 0/68 (0%) | |||
Abscess limb | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Bacteraemia | 0/81 (0%) | 2/53 (3.8%) | 1/68 (1.5%) | |||
Bronchitis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Candida sepsis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Clostridium difficile colitis | 2/81 (2.5%) | 0/53 (0%) | 0/68 (0%) | |||
Diverticulitis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Endocarditis candida | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Escherichia bacteraemia | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Pelvic abscess | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Peritonitis | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Peritonitis bacterial | 2/81 (2.5%) | 0/53 (0%) | 0/68 (0%) | |||
Pneumonia | 2/81 (2.5%) | 0/53 (0%) | 1/68 (1.5%) | |||
Pulmonary sepsis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Renal abscess | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Sepsis | 1/81 (1.2%) | 2/53 (3.8%) | 2/68 (2.9%) | |||
Septic embolus | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Septic shock | 9/81 (11.1%) | 1/53 (1.9%) | 2/68 (2.9%) | |||
Staphylococcal bacteraemia | 0/81 (0%) | 2/53 (3.8%) | 0/68 (0%) | |||
Systemic candida | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Urosepsis | 1/81 (1.2%) | 1/53 (1.9%) | 0/68 (0%) | |||
Injury, poisoning and procedural complications | ||||||
Fall | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Femur fracture | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Gastrointestinal stoma complication | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Post procedural fistula | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Post procedural haemorrhage | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Tracheal haemorrhage | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Vascular pseudoaneurysm | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Investigations | ||||||
Aspiration bronchial | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Metabolism and nutrition disorders | ||||||
Diabetes mellitus | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Hyperkalaemia | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Hyponatraemia | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Metabolic acidosis | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
Malignant neoplasm progression | 2/81 (2.5%) | 0/53 (0%) | 1/68 (1.5%) | |||
Malignant pleural effusion | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Neoplasm malignant | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Post transplant lymphoproliferative disorder | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Nervous system disorders | ||||||
Depressed level of consciousness | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Encephalopathy | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Metabolic encephalopathy | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Neurodegenerative disorder | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Neurological symptom | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Peroneal nerve palsy | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Seizure | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Renal and urinary disorders | ||||||
Acute kidney injury | 1/81 (1.2%) | 1/53 (1.9%) | 0/68 (0%) | |||
Haematuria | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Respiratory, thoracic and mediastinal disorders | ||||||
Acute respiratory distress syndrome | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Acute respiratory failure | 1/81 (1.2%) | 0/53 (0%) | 3/68 (4.4%) | |||
Apnoea | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Aspiration | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Atelectasis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Dyspnoea | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Pleural effusion | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Pneumonia aspiration | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Pneumothorax | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Pulmonary embolism | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Respiratory arrest | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Respiratory failure | 2/81 (2.5%) | 1/53 (1.9%) | 1/68 (1.5%) | |||
Skin and subcutaneous tissue disorders | ||||||
Henoch-Schonlein purpura | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Vascular disorders | ||||||
Arterial haemorrhage | 0/81 (0%) | 1/53 (1.9%) | 0/68 (0%) | |||
Deep vein thrombosis | 0/81 (0%) | 0/53 (0%) | 1/68 (1.5%) | |||
Shock | 1/81 (1.2%) | 0/53 (0%) | 0/68 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
Group 1 | Group 2 | Group 3 | ||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 70/81 (86.4%) | 49/53 (92.5%) | 53/68 (77.9%) | |||
Blood and lymphatic system disorders | ||||||
Anaemia | 6/81 (7.4%) | 7/53 (13.2%) | 4/68 (5.9%) | |||
Gastrointestinal disorders | ||||||
Diarrhoea | 7/81 (8.6%) | 11/53 (20.8%) | 10/68 (14.7%) | |||
Vomiting | 6/81 (7.4%) | 8/53 (15.1%) | 5/68 (7.4%) | |||
Nausea | 4/81 (4.9%) | 8/53 (15.1%) | 6/68 (8.8%) | |||
Abdominal pain | 5/81 (6.2%) | 5/53 (9.4%) | 4/68 (5.9%) | |||
General disorders | ||||||
Pyrexia | 9/81 (11.1%) | 4/53 (7.5%) | 6/68 (8.8%) | |||
Oedema peripheral | 6/81 (7.4%) | 2/53 (3.8%) | 0/68 (0%) | |||
Metabolism and nutrition disorders | ||||||
Hypokalaemia | 13/81 (16%) | 9/53 (17%) | 9/68 (13.2%) | |||
Psychiatric disorders | ||||||
Insomnia | 4/81 (4.9%) | 4/53 (7.5%) | 2/68 (2.9%) | |||
Skin and subcutaneous tissue disorders | ||||||
Decubitus ulcer | 4/81 (4.9%) | 3/53 (5.7%) | 3/68 (4.4%) | |||
Vascular disorders | ||||||
Hypotension | 6/81 (7.4%) | 2/53 (3.8%) | 4/68 (5.9%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
Name/Title | Taylor Sandison, M.D., MPH |
---|---|
Organization | Cidara Therapeutics, Inc. |
Phone | 858-888-7868 |
clinicaltrialinfo@cidara.com |
- CD101.IV.2.03
- 2015-005599-51