NCT01945281

Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)

A Multicenter, Double-Blind, Randomized, Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants Less Than 3 Months of Age

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Candidiasis, Invasive

Interventions

Type	Name	Description
DRUG	Caspofungin
DRUG	Amphotericin B Deoxycholate

Timeline

• Start date: 2014-01-15
• Primary completion: 2018-01-02
• Completion: 2018-02-28
• First posted: 2013-09-18
• Last updated: 2019-11-25
• Results posted: 2018-08-28