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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00330395
Recruitment Status : Completed
First Posted : May 26, 2006
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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).

Condition or disease Intervention/treatment Phase
Candidiasis Drug: caspofungin acetate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2006
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Intervention Details:
  • Drug: caspofungin acetate
    Duration of Treatment 28 Days
    Other Name: MK0991

Primary Outcome Measures :
  1. Pharmacokinetic parameters of drug exposure

Secondary Outcome Measures :
  1. Safety and tolerability

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00330395

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00330395    
Other Study ID Numbers: 0991-058
First Posted: May 26, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action