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)

NCT01945281

Phase 2 Terminated 51 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject Caspofungin Other / unclassified 2 mg/kg Intravenous
Comparator amphotericin B deoxycholate Unknown 1 mg/kg Intravenous

Indications