Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis (NCT00412893) | Clinical Trial Compass
CompletedPhase 3
Isavuconazole (BAL8557) for Primary Treatment of Invasive Aspergillosis
United States527 participantsStarted 2007-03-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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