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

• Status: Terminated
• Trial end date: 2018-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Amphotericin B; Amphotericin B, deoxycholate drug combination; Caspofungin; Deoxycholic Acid; Echinocandins; Liposomal amphotericin B

Criteria

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