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

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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.


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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Sao Paulo,
Phone: 55 11 51897942
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Sao Paulo,
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