Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03667690 | Study of Rezafungin Compared to Caspofungin in Subjects With Candidemia and/or Invasive Candidiasis | PHASE3 | COMPLETED | 199 | — | — | Oct 7, 2018 | Oct 7, 2021 | Jan 6, 2023 | 132 | United States, Argentina +16 |
The number and percentage of subjects in each treatment group who are alive and deceased (or with missing data) in the mITT population.
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.
| Arm | Type | Description |
|---|---|---|
| Group 1: Rezafungin for Injection | EXPERIMENTAL | Subjects in Rezafungin treatment group will receive a 400 mg loading dose in Week 1, followed by 200 mg once weekly, for a total of 2 to 4 doses. Daily intravenous placebo infusions, when not administered Rezafungin and a daily placebo for oral step-down therapy (first eligibility on Day 4 or later as advised by a site's national/regional/local guidelines) administered every day. |
| Group 2: Caspofungin | ACTIVE_COMPARATOR | Subjects in caspofungin arm will receive a total treatment of ≥14 days beginning with a single caspofungin 70 mg IV loading dose on Day 1 followed by 50 mg IV once daily up to 28 days. After ≥3 days of caspofungin treatment(or the minimum duration of IV therapy advised by the site's national/regional/local guidelines, whichever is greater), subjects may be switched to oral fluconazole if specific parameters are met. If the subject qualifies, then oral step-down therapy of fluconazole (6 mg/kg to the nearest 200 mg) is administered. 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. |
| Name | Type | Description |
|---|---|---|
| Rezafungin for Injection | DRUG | Intravenous antifungal therapy |
| Caspofungin | DRUG | Intravenous antifungal therapy |
| Fluconazole | DRUG | Oral antifungal therapy |
| intravenous placebo | DRUG | Normal saline |
| oral placebo | DRUG | Microcrystalline cellulose |
Inclusion Criteria: 1. 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 his/her behalf. 2. Males or females ≥18 years of age. 3. Established mycological diagnosis of ca...