Trial · NCT03667690
Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
NCT03667690, Phase 3, Completed, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2023-01-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis. Trials, record NCT03667690. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03667690
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis
- NCT number
- NCT03667690
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 199 participants, actual
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Candidemia, Mycoses, Fungal Infection, Invasive Candidiases
- Interventions
- Rezafungin for Injection, Caspofungin, Fluconazole, intravenous placebo, oral placebo
- First posted
- 2018-09-12
- Last updated
- 2023-01-06
- Results first posted
- 2023-01-06
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | All-Cause Mortality (US FDA Only) | Day 30 (-2 days) | The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population. |
| Primary | Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Day 14 (±1 day) | The number and percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure \[for qualifying invasive candidiasis subjects at baseline\], and mycological eradication, as confirmed by the Data Review Committee \[DRC\]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol. |
| Secondary | Global Response as Assessed by Data Review Committee (US FDA Only) | Day 14 (±1 day) | The number and percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure \[for qualifying invasive candidiasis subjects at baseline\], and mycological eradication, as confirmed by the Data Review Committee \[DRC\]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol. |
| Secondary | All-Cause Mortality (EU EMA Only) | Day 30 (-2 days) | The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population. |
| Secondary | Comparison of Global Response (as Assessed by the DRC) by Visit | Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59) | The number and percentage of subjects in each treatment group who have a global response of cure (clinical cure as assessed by the Investigator, radiological cure \[for qualifying invasive candidiasis subjects at baseline\], and mycological eradication, as confirmed by the Data Review Committee \[DRC\]), failure and indeterminate in the mITT population. A global response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the global responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 7 (Global Response) of the clinical protocol. |
| Secondary | Comparison of Mycological Eradication by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The number and percentage of subjects in each treatment group who have a mycological response of eradication, failure, or indeterminate in the mITT population. A mycological response of eradication means clearance of objective evidence of infection and is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was eradication or failure. Definitions for the mycological responses of eradication, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 8 (Mycological Response) of the clinical protocol. Note: Eradication includes both documented and presumed eradication. |
| Secondary | Comparison of Investigators' Assessment of Clinical Response by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The number and percentage of subjects in each treatment group for whom the Investigator determined a clinical response of cure, failure, or indeterminate in the mITT population. A clinical response of cure, as assessed by the Investigator, is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the clinical responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 9 (Investigator's Assessment of Clinical Response) of the clinical protocol. |
| Secondary | Comparison of Radiological Response by Investigator by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The number and percentage of subjects with invasive candidiasis (documented by radiologic/imaging evidence at baseline) in each treatment group who have a radiological response (as assessed by the Investigator) of cure, failure, and indeterminate in the mITT population. A radiological response of cure is indicative of an efficacious outcome and the desired result, whereas a response of failure is indicative of a non-efficacious outcome and the undesired response. Indeterminate responses indicate there was not enough data obtained to determine if the response was cure or failure. Definitions for the radiological responses of cure, failure, and indeterminate are complex. Detailed definitions for the possible responses to this outcome measure type are provided in Table 10 (Radiological Response) of the clinical protocol. |
| Secondary | Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] | Day 1 through Follow-up Visit (Days 52-59) | The number and percentage of subjects in each treatment group that experienced at least one treatment-emergent adverse event (TEAE) based on clinical chemistry, hematology and urine analysis laboratory test, vital sign, physical exams and electrocardiogram (ECG) abnormalities. Notes: A subject with multiple adverse events (AEs) was counted only once. TEAE was defined as an AE that occurred during or after study drug administration and up through the Follow-up visit. The maximum severity and strongest relationship were counted for subjects with multiple events. |
| Secondary | Evaluate Pharmacokinetics (Cmax) | Day 1, 10 minutes before the end of infusion | Evaluate the maximum plasma concentration (Cmax) of rezafungin for injection. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | All-Cause Mortality (US FDA Only) | Day 30 (-2 days) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Day 14 (±1 day) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Global Response as Assessed by Data Review Committee (US FDA Only) | Day 14 (±1 day) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All-Cause Mortality (EU EMA Only) | Day 30 (-2 days) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Global Response (as Assessed by the DRC) by Visit | Day 5, Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose) and Follow-up (Days 52-59) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Mycological Eradication by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Investigators' Assessment of Clinical Response by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Comparison of Radiological Response by Investigator by Visit | Day 5, Day 14 (±1 day), Day 30 (-2 days), End of Treatment (EOT) (≤2 days of last dose), and Follow-up (Days 52-59) | The modified Intent-to-Treat (mITT) Population includes all subjects who had a documented Candida infection based on central laboratory evaluation of a blood culture or a culture from a normally sterile site obtained ≤4 days (96 hours) before randomization and received ≥1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Treatment-Emergent Adverse Events [Safety and Tolerability] | Day 1 through Follow-up Visit (Days 52-59) | The Safety Population includes all subjects who received any amount of the study drug. Safety analyses were performed on the Safety Population. Subjects who received the wrong study drug for their entire course of study drug were analyzed in the treatment group based on the drug received. Subjects who received the wrong study drug for part of their course of study drug were analyzed in the treatment group based on majority of (i.e., most frequent) doses received. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Evaluate Pharmacokinetics (Cmax) | Day 1, 10 minutes before the end of infusion | The Pharmacokinetic (PK) Population includes all subjects who received any amount of study drug and had at least one blood sample with measurable concentrations.~Note: Although blood samples were collected from all subjects receiving study drug, only PK samples from subjects receiving rezafungin for injection were analyzed. | micrograms/milliliter | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| All-Cause Mortality (US FDA Only) | Group 1: Rezafungin for Injection | Deceased: Known Deceased (subjects who died on or before Day 30) | 19 | Participants | |
| All-Cause Mortality (US FDA Only) | Group 2: Caspofungin | Deceased: Known Deceased (subjects who died on or before Day 30) | 17 | Participants | |
| All-Cause Mortality (US FDA Only) | Group 1: Rezafungin for Injection | Deceased: Unknown Survival Status | 3 | Participants | |
| All-Cause Mortality (US FDA Only) | Group 2: Caspofungin | Deceased: Unknown Survival Status | 3 | Participants | |
| All-Cause Mortality (US FDA Only) | Group 1: Rezafungin for Injection | Alive | 71 | Participants | |
| All-Cause Mortality (US FDA Only) | Group 2: Caspofungin | Alive | 74 | Participants | |
| Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Group 1: Rezafungin for Injection | Cure | 55 | Participants | |
| Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Group 2: Caspofungin | Cure | 57 | Participants | |
| Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Group 1: Rezafungin for Injection | Failure | 28 | Participants | |
| Global Response as Assessed by Data Review Committee (EU European Medicines Agency [EMA] Only) | Group 2: Caspofungin | Failure | 29 | Participants |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1: Rezafungin for Injection | 100 | |
| Overall Study | STARTED | Group 2: Caspofungin | 99 | |
| Overall Study | Completed Study Drug Regimen Through Study Day 14 | Group 1: Rezafungin for Injection | 66 | |
| Overall Study | Completed Study Drug Regimen Through Study Day 14 | Group 2: Caspofungin | 71 | |
| Overall Study | COMPLETED | Group 1: Rezafungin for Injection | 59 | |
| Overall Study | COMPLETED | Group 2: Caspofungin | 59 | |
| Overall Study | NOT COMPLETED | Group 1: Rezafungin for Injection | 41 | |
| Overall Study | NOT COMPLETED | Group 2: Caspofungin | 40 |
Source ClinicalTrials.gov
Adverse events250
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pyrexia | General disorders | Group 1: Rezafungin for Injection | 14 | 98 | |
| other | Pyrexia | General disorders | Group 2: Caspofungin | 5 | 98 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Group 1: Rezafungin for Injection | 12 | 98 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Group 2: Caspofungin | 9 | 98 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 1: Rezafungin for Injection | 9 | 98 | |
| other | Anaemia | Blood and lymphatic system disorders | Group 2: Caspofungin | 9 | 98 | |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Group 1: Rezafungin for Injection | 7 | 98 | |
| other | Hypomagnesaemia | Metabolism and nutrition disorders | Group 2: Caspofungin | 3 | 98 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 1: Rezafungin for Injection | 6 | 98 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 2: Caspofungin | 7 | 98 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1: Rezafungin for Injection | 29 | 98 |
| Total, all-cause mortality | Group 2: Caspofungin | 25 | 98 |
| Total, other adverse events | Group 1: Rezafungin for Injection | 90 | 98 |
| Total, other adverse events | Group 2: Caspofungin | 66 | 98 |
| Total, serious adverse events | Group 1: Rezafungin for Injection | 55 | 98 |
| Total, serious adverse events | Group 2: Caspofungin | 52 | 98 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1: Rezafungin for Injection vs Group 2: Caspofungin: deaths from any cause | Trial comparisons |
| Group 1: Rezafungin for Injection vs Group 2: Caspofungin: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03667690
GET https://conductscience.org/api/trials/v1/NCT03667690/results?page=2