drugset / Trial / NCT00413218
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.
Timeline
- Start
- 2007-03-08
- Primary completion
- 2015-03-03
- Completion
- 2015-03-03
Outcome
Missed primary endpoint
paper This study did not demonstrate non-inferiority of isavuconazole to caspofungin for primary treatment of invasive candidiasis. PMID 30289478 ↗
paper Successful overall response at EOIVT was observed in 60.3% of patients in the isavuconazole arm and 71.1% in the caspofungin arm (adjusted difference -10.8, 95% confidence interval -19.9--1.8). PMID 30289478 ↗
release “The isavuconazole phase 3 ACTIVE study in invasive Candida infections did not meet its primary endpoint.” basilea.com ↗
Publications
- Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.
- McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Caspofungin | Other / unclassified | 50 mg | Intravenous |
| Comparator | Caspofungin | Other / unclassified | 70 mg | Intravenous |
| Subject | Isavuconazole | Small molecule | 200 mg | Intravenous |
| Comparator | Voriconazole | Small molecule | 200 mg | Intravenous |