Clinical Research Details

Descriptive Information
A phase III, Double Blind, Randomized Study to Evaluate the Safety and Efficacy of BAL-8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections.

Souha Kanj
sk11@aub.edu.lb

WSA-CS-008
Completed

Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 3  

No
Collaborators
  • Christopher Lademacher
  • Marie Rosenfeld
  • Siobhan M. Gallagher
Sponsors
  • Astellas Pharma Global Development, Inc
Conditions and Keywords
Candidemia and Other Inavasive Candida Infections
Isavuconazole, Candidemia, Invasive Candida Infections
Study Design
Treatment
Efficacy Study
Double Blind
Parallel
Randomized
Eligibility and IRB
Both
Min: 18
Max:
Yes
No







Age>18, in-patients with candidemia or with invasive candida infections with positive blood or tissue culture, fever or hypothermia or hypotension, or local signs, not to participate in any other clinical trial.


Women pregnant or breastfeeding, allergy to azole or echinocandin, patients for whom caspofungin or voriconazole in contraindicated, high risk for QTc prolonguation, Hepatic dysfunction, concomitant use of inducers drugs in 5 days of drug, sole diagnosis of mucocutaneous or UTI candida, candidemia that failed previous antifungal therapy, invasive fungal disease other than candida, alternative etiology to the patient's symptoms, patients who received systemic antifungals, immunosupresion, fungal endocarditis, osteomyelitis, meningitis, low life expectency, risky concomitant medical condition, previously enrolled in a phase II study with isavuconazole, enroolled in another clinical trial, weight<40 kg, congenital QT syndrome.