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

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.

Inclusion Criteria:

• Culture-confirmed invasive Candida infection

Exclusion Criteria:

• Candida disease limited to the oropharynx, esophagus, or other mucosal or superficial skin surfaces
• Positive culture for Candida only from sputum, broncho-alveolar lavage, catheter tip, or previously placed indwelling non-vascular catheters or drains
• Prosthetic device as the suspected site of Candida infection
• Active co-infection with a non-Candida fungal organism
• Received >48 hours of systemic antifungal treatment since the positive Candida index culture was collected as therapy for the present episode of invasive candidiasis
• Failed prior systemic antifungal therapy for the present episode of invasive candidiasis
• Diagnosis of acute hepatitis or cirrhosis
• Scheduled or anticipated to receive rifampin or other systemic antifungal therapy while on study therapy
• History (including participant's mother) of allergy, hypersensitivity, or any serious reaction to caspofungin or other member of the echinocandin class, or to amphotericin B deoxycholate or other member of the polyene class
• Severe congenital disorder known to lower immune response