Phase 3
Completed N=527
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
Aspergillosis · Invasive Fungal Infection
Source: ClinicalTrials.gov NCT00412893 ↗
Enrolled (actual)
527
Serious AEs
54.8%
Results posted
Mar 2015
Primary outcomePrimary: All-cause Mortality Through Day 42 — 18.6; 20.2 percentage of participants
Summary
The purpose of this study is to compare the efficacy and safety of isavuconazole versus voriconazole in the treatment of patients with invasive aspergillosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality Through Day 42 |
18.6; 20.2 | — |
| SECONDARY Percentage of Participants With an Overall Outcome of Success Evaluated by the Data Review Committee (DRC) |
35.7; 35.7; 25.2; 32.6; 35.0; 36.4 | — |
| SECONDARY All-cause Mortality Through Day 84 |
29.1; 31.0 | — |
| SECONDARY Percentage of Participants With an Overall Outcome of Success Evaluated by Investigator |
— | — |
| SECONDARY Percentage of Participants With a Clinical Response Assessed by the DRC |
64.0; 57.5; 46.1; 44.4; 62.0; 60.3 | — |
| SECONDARY Percentage of Participants With a Mycological Response Assessed by the DRC |
39.9; 39.5; 28.0; 36.4; 37.8; 41.1 | — |
| SECONDARY Percentage of Participants With a Radiological Response Assessed by the DRC |
28.4; 34.4; 22.0; 29.7; 29.1; 33.1 | — |
| SECONDARY Percentage of Participants With a Clinical Response Assessed by the Investigator |
64.2; 61.7; 41.4; 44.3; 62.0; 64.5 | — |
| SECONDARY Percentage of Participants With a Mycological Response Assessed by the Investigator |
52.3; 50.0; 35.7; 37.6; 50.5; 55.0 | — |
| SECONDARY Percentage of Participants With a Radiological Response Assessed by the Investigator |
45.1; 51.6; 38.3; 41.4; 43.3; 47.7 | — |
| SECONDARY Number of Participants With Adverse Events, Reported by System Organ Class |
247; 255; 174; 180; 152; 158 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have proven, probable or possible invasive fungal disease caused by Aspergillus species or other filamentous fungi
- Female patients must be non-lactating and at no risk for pregnancy
Exclusion Criteria
- Patients with invasive fungal infections other than Aspergillus species or other filamentous fungi
- Evidence of hepatic dysfunction at Baseline or moderate to severe renal dysfunction
- Patients with chronic aspergillosis, or aspergilloma or allergic bronchopulmonary aspergillosis
- Patients who have received more than 4 days of systemic antifungal therapy other than fluconazole within the 7 days prior to the first administration of study medication
- Patients previously enrolled in a Phase III study with isavuconazole
- Patients with a body weight </= 40 kg
Data sourced from ClinicalTrials.gov (NCT00412893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.