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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02629419 | CAMB/MAT2203 in Patients With Mucocutaneous Candidiasis | PHASE2 | COMPLETED | 4 | — | — | Sep 27, 2016 | Aug 6, 2022 | Aug 7, 2024 | 1 | United States |
Number of subjects with a clinical response of clinical cure or improvement. Clinical cure was defined as absence of signs or symptoms of infection. Clinical improvement was defined as follows: * OPC or EC: partial resolution defined as greater than or equal to 50% of Baseline signs or symptoms * VVC: reduction of greater than or equal to 50% of clinical severity score from Baseline Severity of each symptom was graded on a scale from zero (absence of symptoms) to 3 (severe symptoms). The sum of all scores for all symptoms was used as the clinical severity score. Higher scores mean worse outcomes.
| Arm | Type | Description |
|---|---|---|
| CAMB (Encochleated Amphotericin B) | EXPERIMENTAL | Encochleated Amphotericin B (200 mg, 400 mg, 800 mg) |
| Name | Type | Description |
|---|---|---|
| Amphotericin B | DRUG | Oral lipid nanocrystal formulation of amphotericin B |
Inclusion Criteria: * Patients must have a clinical diagnosis of at least one of the following: * Persistent oropharyngeal candidiasis (OPC) for greater than or equal to 5 days documented on at least one occasion by potassium hydroxide (KOH) test or fungal stain and confirmed by mycological culture...