Status:
COMPLETED
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Candidiasis
Eligibility:
All Genders
Up to 3 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test ...
Eligibility Criteria
Inclusion
- Neonates and infants \<3 months of age
- Patient has a body weight greater than or equal to 500 grams
- Patient has documented or highly suspected Candida infection
Exclusion
- Patient is greater than 3 months of age
- Patient has a body weight of less than 500 grams
- Patient does not meet certain laboratory testing criteria
- Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
- Patient has documented HIV infection of any stage
- Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00330395
Start Date
May 1 2006
End Date
October 1 2006
Last Update
February 23 2017
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