drugset / Trial / NCT01945281
Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
RandomizedParallel-groupDouble-blindTreatment
Summary
The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants. The primary hypothesis to be tested in the study is that caspofungin will be superior to amphotericin B deoxycholate with regard to the proportion of participants with fungal-free survival at the 2-week post-therapy follow-up visit.
Timeline
- Start
- 2014-01-15
- Primary completion
- 2018-01-02
- Completion
- 2018-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caspofungin | Other / unclassified | 2 mg/kg | Intravenous |
| Comparator | amphotericin B deoxycholate | Unknown | 1 mg/kg | Intravenous |