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Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)

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.
 
ClinicalTrials.gov Identifier: NCT00292071
Recruitment Status : Completed
First Posted : February 15, 2006
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Study Description
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Brief Summary:
This is an open-label study of MK0991 in children between 3 to 24 months of age with new onset fever and neutropenia. The purpose of the study is to investigate plasma drug levels of caspofungin.

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

Study Design
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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, Open, Sequential Dose-Escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics of 2 Separate Doses of Caspofungin Acetate in Children Between the Ages of 3 to 24 Months With New Onset Fever and Neutropenia
Study Start Date : May 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arms and Interventions
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Arm Intervention/treatment
1
IV caspofungin acetate (50 mg/m²/day)
 Drug: caspofungin acetate
(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
Other Names:
  • MK0991
  • CANCIDAS®
2
IV caspofungin acetate (70 mg/m²/day)
 Drug: caspofungin acetate
(50 mg/m²/day and 70 mg/m²/day) Caspofungin will be given for a minimum of 4 days (or at least 2 separate days of 7-point plasma sampling). Patients will be administered caspofungin for a maximum of 28 days.
Other Names:
  • MK0991
  • CANCIDAS®


Outcome Measures
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Primary Outcome Measures :
  1. Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ]

Eligibility Criteria
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Ages Eligible for Study:   3 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient is 3 to 24 months of age with one or more of the following conditions:
  • Leukemia, lymphoma, or other cancers
  • Bone marrow or peripheral stem transplantation
  • High dose chemotherapy leading to a decrease in white blood cells
  • Aplastic anemia
  • Patient has an absolute neutrophil count <500 mm3 (a specific type of white blood cell that fights infection) AND at least one recording of fever > 38 degreesC (oral or oral equivalent) within 72 hours of screening.

Exclusion Criteria:

  • Patient is <3 months or >24 months of age at the time of study drug administration
  • Patient has proven or probable invasive fungal infection at the time of enrollment
  • Patient has certain blood clotting or liver function abnormalities
  • Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days
  • Patient is taking rifampin, cyclosporin A, phenytoin, carbamazepine, or phenobarbital.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00292071


Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme LLC
More Information
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Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications:

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Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT00292071    
Other Study ID Numbers: 0991-042
MK0991-042
2005_099
First Posted: February 15, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Mycoses
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Bacterial Infections and Mycoses
 Infections
Caspofungin
Antifungal Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action