A Phase 2 interventional study of CD101 and Caspofungin in Candidemia, Mycoses and Fungal Infection, sponsored by Cidara Therapeutics Inc.. Completed at 63 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-08.
Sponsored by Cidara Therapeutics Inc. (part of Merck & Co., Inc) · Phase 2, Interventional, and Treatment
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).
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).
73 studies on the registry are indexed under Candidemia; 5 are open to participants now.
This study's enrollment of 207 is above the median of 63 across 44 interventional studies indexed under Candidemia.
Browse Candidemia studies →Cidara Therapeutics Inc. is the lead sponsor of 9 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
First submitted before Cidara Therapeutics Inc. became part of Merck & Co., Inc.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Any of the following forms of IC:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 · Drug: intravenous placebo · Drug: oral placebo
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 · Drug: Fluconazole · Drug: intravenous placebo
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 · Drug: intravenous placebo · Drug: oral placebo
Intravenous antifungal therapy
Also known as: CD101 for Injection
Intravenous antifungal therapy
Also known as: Cancidas
oral antifungal therapy
Also known as: generic fluconazole
normal saline
Also known as: placebo infusion
microcrystalline cellulose
Also known as: encapsulated cellulose
Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
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.
Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success]
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)
Mycological Eradication and Resolution of Systemic Signs
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.
Mycological Eradication
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)
Clinical Cure
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).
Evaluate PK (Cmax)
Evaluate maximum plasma concentration (Cmax) (Part A only)
Time frame: Day 1, 10 minutes before end of infusion (EOI)
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time frame: Day 8, predose
Evaluate PK (Cmin)
Evaluate minimum plasma concentration (Cmin) (Part A only)
Time frame: Day 15, predose
| Milestone | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Started | 35 | 36 | 36 |
| Completed | 23 | 28 | 22 |
| Not completed | 12 | 8 | 14 |
| Withdrew: Death | 3 | 4 | 6 |
| Withdrew: Lost to follow-up | 2 | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 |
| Withdrew: Physician decision | 2 | 0 | 1 |
| Withdrew: Adverse event | 2 | 0 | 1 |
| Withdrew: Noncompliance | 1 | 1 | 0 |
| Withdrew: Other | 1 | 1 | 3 |
| Milestone | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Started | 46 | 21 | 33 |
| Completed | 33 | 14 | 28 |
| Not completed | 13 | 7 | 5 |
| Withdrew: Death | 8 | 3 | 5 |
| Withdrew: Lost to follow-up | 2 | 2 | 0 |
| Withdrew: Withdrawal by subject | 3 | 1 | 0 |
| Withdrew: Other | 0 | 1 | 0 |
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.
| Participants | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | 71 | 49 | 55 |
Number of subjects with mycological eradication and complete resolution of all systemic signs of candidemia and/or invasive candidiasis which were present at baseline
| Participants | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | 46 | 35 | 41 |
Evaluate overall success signs (mycological eradication and resolution of systemic signs attributable to candidemia and/or IC) in the mITT population.
| Participants | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Day 5 | 42 | 34 | 34 |
| Follow-up | 36 | 30 | 36 |
Evaluate mycological success (eradication) in the mITT population.
| Participants | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Day 5 | 50 | 35 | 38 |
| Day 14 | 50 | 35 | 42 |
| Follow-up | 39 | 30 | 36 |
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
| Participants | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Day 14 | 53 | 37 | 43 |
| Follow-up | 42 | 32 | 38 |
Evaluate maximum plasma concentration (Cmax) (Part A only)
| μg/mL | Group 1 | Group 2 |
|---|---|---|
| Evaluate PK (Cmax) | 15.258 ± 5.5430 | 14.743 ± 5.6450 |
Evaluate minimum plasma concentration (Cmin) (Part A only)
| μg/mL | Group 1 | Group 2 |
|---|---|---|
| Evaluate PK (Cmin) | 2.050 ± 0.9767 | 2.313 ± 1.2165 |
Evaluate minimum plasma concentration (Cmin) (Part A only)
| μg/mL | Group 1 | Group 2 |
|---|---|---|
| Evaluate PK (Cmin) | 3.068 ± 1.4565 | 2.131 ± 0.8506 |
Collected over 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).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1 | 14/81 (17.3%) | 35/81 (43.2%) | 70/81 (86.4%) |
| Group 2 | 7/57 (12.3%) | 28/53 (52.8%) | 49/53 (92.5%) |
| Group 3 | 13/69 (18.8%) | 29/68 (42.6%) | 53/68 (77.9%) |
| Event | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| Septic shockInfections and infestations | 9/81 | 1/53 | 2/68 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/81 | 0/53 | 3/68 |
| BacteraemiaInfections and infestations | 0/81 | 2/53 | 1/68 |
| SepsisInfections and infestations | 1/81 | 2/53 | 2/68 |
| Staphylococcal bacteraemiaInfections and infestations | 0/81 | 2/53 | 0/68 |
| Multiple organ dysfunction syndromeGeneral disorders | 2/81 | 0/53 | 2/68 |
| Gastrointestinal haemorrhageGastrointestinal disorders | 2/81 | 1/53 | 0/68 |
| Clostridium difficile colitisInfections and infestations | 2/81 | 0/53 | 0/68 |
| Peritonitis bacterialInfections and infestations | 2/81 | 0/53 | 0/68 |
| PneumoniaInfections and infestations | 2/81 | 0/53 | 1/68 |
| Event | Group 1 | Group 2 | Group 3 |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 7/81 | 11/53 | 10/68 |
| HypokalaemiaMetabolism and nutrition disorders | 13/81 | 9/53 | 9/68 |
| VomitingGastrointestinal disorders | 6/81 | 8/53 | 5/68 |
| NauseaGastrointestinal disorders | 4/81 | 8/53 | 6/68 |
| AnaemiaBlood and lymphatic system disorders | 6/81 | 7/53 | 4/68 |
| PyrexiaGeneral disorders | 9/81 | 4/53 | 6/68 |
| Abdominal painGastrointestinal disorders | 5/81 | 5/53 | 4/68 |
| InsomniaPsychiatric disorders | 4/81 | 4/53 | 2/68 |
| HypotensionVascular disorders | 6/81 | 2/53 | 4/68 |
| Oedema peripheralGeneral disorders | 6/81 | 2/53 | 0/68 |
The Intent-to-Treat (ITT) population analyzed consisted of all subjects randomized to treatment. Subjects were analyzed based on the treatment group to which they were randomized.
| Age, Categorical(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 49 | 32 | 40 | 121 |
| >=65 years | 32 | 25 | 29 | 86 |
| Age, Continuous(Years) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Mean | 59.4 ± 15.86 | 60.0 ± 15.90 | 59.4 ± 15.85 | 59.6 ± 15.79 |
| Age, Continuous(years) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Median | 61.0 (24.0 to 88.0) | 63.0 (24.0 to 91.0) | 63.0 (24.0 to 93.0) | 62.0 (24.0 to 93.0) |
| Sex: Female, Male(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Female | 37 | 21 | 31 | 89 |
| Male | 44 | 36 | 38 | 118 |
| Ethnicity (NIH/OMB)(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 8 | 9 | 7 | 24 |
| Not Hispanic or Latino | 73 | 46 | 59 | 178 |
| Unknown or Not Reported | 0 | 2 | 3 | 5 |
| Race (NIH/OMB)(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 3 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 8 | 7 | 4 | 19 |
| White | 69 | 44 | 59 | 172 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 5 | 3 | 12 |
| Region of Enrollment(participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Greece | 6 | 6 | 8 | 20 |
| Canada | 1 | 1 | 3 | 5 |
| Romania | 2 | 0 | 3 | 5 |
| Belgium | 9 | 9 | 12 | 30 |
| Hungary | 2 | 0 | 0 | 2 |
| United States | 26 | 22 | 23 | 71 |
| Italy | 7 | 2 | 5 | 14 |
| Bulgaria | 4 | 1 | 2 | 7 |
| Russia | 2 | 1 | 0 | 3 |
| Spain | 22 | 15 | 13 | 50 |
| Diagnosis(Participants) | Group 1 | Group 2 | Group 3 | Total |
|---|---|---|---|---|
| Candidemia | 62 | 46 | 56 | 164 |
| Invasive Candidiasis | 19 | 11 | 13 | 43 |
5 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jul 2016 to primary completion in Jun 2019, 35 months.
Results were first posted in Dec 2020, 1 year 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Rezafungin