Back to resultsOpen, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
Primary Purpose
Candidiasis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
caspofungin acetate
Sponsored by
About this trial
This is an interventional treatment trial for Candidiasis
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Pharmacokinetic parameters of drug exposure
Secondary Outcome Measures
Safety and tolerability
Full Information
NCT ID
NCT00330395
First Posted
May 24, 2006
Last Updated
February 20, 2017
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00330395
Brief Title
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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 the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
caspofungin acetate
Other Intervention Name(s)
MK0991
Intervention Description
Duration of Treatment 28 Days
Primary Outcome Measure Information:
Title
Pharmacokinetic parameters of drug exposure
Secondary Outcome Measure Information:
Title
Safety and tolerability
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19075070
Citation
Saez-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. Epub 2008 Dec 15.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
We'll reach out to this number within 24 hrs