Safety, Tolerability, and Efficacy of Caspofungin Versus Amphotericin B Deoxycholate in the Treatment of Invasive Candidiasis in Neonates and Infants (MK-0991-064)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/27/2017 |
| Start Date: | January 2014 |
| End Date: | November 2018 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
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 posttherapy follow-up visit.
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 posttherapy 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
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