Trial · NCT02734862
CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
NCT02734862, Phase 2, Completed, Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2020-12-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension. Trials, record NCT02734862. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02734862
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension
- NCT number
- NCT02734862
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 207 participants, actual
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Candidemia, Mycoses, Fungal Infection, Fungemia, Invasive Candidiasis
- Interventions
- CD101, Caspofungin, Fluconazole, intravenous placebo, oral placebo
- First posted
- 2016-04-12
- Last updated
- 2020-12-08
- Other registries' IDs
- eudract:2015-005599-51
- Results first posted
- 2020-12-08
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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 |
| Secondary | Evaluate PK (Cmax) | Day 1, 10 minutes before end of infusion (EOI) | Evaluate maximum plasma concentration (Cmax) (Part A only) |
| Secondary | Evaluate PK (Cmin) | Day 8, predose | Evaluate minimum plasma concentration (Cmin) (Part A only) |
| Secondary | Evaluate PK (Cmin) | Day 15, predose | Evaluate minimum plasma concentration (Cmin) (Part A only) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Day 14 (± 1 day) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 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). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluate PK (Cmax) | Day 1, 10 minutes before end of infusion (EOI) | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | μg/mL | MEAN |
| SECONDARY | Evaluate PK (Cmin) | Day 8, predose | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | μg/mL | MEAN |
| SECONDARY | Evaluate PK (Cmin) | Day 15, predose | PK Population: all rezafungin-treated subjects from Part A with at least 1 plasma sample obtained for PK analysis. | μg/mL | MEAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Group 1 | 71 | Participants | ||
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Group 2 | 49 | Participants | ||
| Incidence of Treatment Emergent Adverse Events [Safety and Tolerability] | Group 3 | 55 | Participants | ||
| Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Group 1 | 46 | Participants | ||
| Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Group 2 | 35 | Participants | ||
| Resolution of Systemic Signs Attributable to Candidemia and/or Invasive Candidiasis and Mycological Eradication [Overall Success] | Group 3 | 41 | Participants | ||
| Mycological Eradication and Resolution of Systemic Signs | Group 1 | Day 5 | 42 | Participants | |
| Mycological Eradication and Resolution of Systemic Signs | Group 2 | Day 5 | 34 | Participants | |
| Mycological Eradication and Resolution of Systemic Signs | Group 3 | Day 5 | 34 | Participants | |
| Mycological Eradication and Resolution of Systemic Signs | Group 1 | Follow-up | 36 | Participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A | STARTED | Group 1 | 35 | |
| Part A | STARTED | Group 2 | 36 | |
| Part A | STARTED | Group 3 | 36 | |
| Part A | COMPLETED | Group 1 | 23 | |
| Part A | COMPLETED | Group 2 | 28 | |
| Part A | COMPLETED | Group 3 | 22 | |
| Part A | NOT COMPLETED | Group 1 | 12 | |
| Part A | NOT COMPLETED | Group 2 | 8 | |
| Part A | NOT COMPLETED | Group 3 | 14 | |
| Part B | STARTED | Group 1 | 46 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events294
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 | Hypokalaemia | Metabolism and nutrition disorders | Group 1 | 13 | 81 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Group 2 | 9 | 53 | |
| other | Hypokalaemia | Metabolism and nutrition disorders | Group 3 | 9 | 68 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 1 | 7 | 81 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 2 | 11 | 53 | |
| other | Diarrhoea | Gastrointestinal disorders | Group 3 | 10 | 68 | |
| other | Vomiting | Gastrointestinal disorders | Group 1 | 6 | 81 | |
| other | Vomiting | Gastrointestinal disorders | Group 2 | 8 | 53 | |
| other | Vomiting | Gastrointestinal disorders | Group 3 | 5 | 68 | |
| other | Pyrexia | General disorders | Group 1 | 9 | 81 |
1 to 10 of 294Source ClinicalTrials.gov
See all 294 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 14 | 81 |
| Total, all-cause mortality | Group 2 | 7 | 57 |
| Total, all-cause mortality | Group 3 | 13 | 69 |
| Total, other adverse events | Group 1 | 70 | 81 |
| Total, other adverse events | Group 2 | 49 | 53 |
| Total, other adverse events | Group 3 | 53 | 68 |
| Total, serious adverse events | Group 1 | 35 | 81 |
| Total, serious adverse events | Group 2 | 28 | 53 |
| Total, serious adverse events | Group 3 | 29 | 68 |
Source ClinicalTrials.gov
Papers6
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02734862
GET https://conductscience.org/api/trials/v1/NCT02734862/results?page=2