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NCT00330395 Clinical Trial

Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)

Candidiasis Clinical Trial

Official title:
A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00330395
Other study ID # 0991-058
Secondary ID MK0991-0582006_0
Status Completed
Phase Phase 2
First received May 24, 2006
Last updated February 20, 2017
Start date May 2006
Est. completion date October 2006

Study information
Verified date February 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date October 2006
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender All
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• caspofungin acetate
Duration of Treatment 28 Days

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Sáez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetic parameters of drug exposure
Secondary Safety and tolerability
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