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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00292071
First received: February 14, 2006
Last updated: February 20, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Fungal Infection Drug: caspofungin acetate Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

Enrollment: 16
Study Start Date: May 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292071

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00292071     History of Changes
Other Study ID Numbers: 0991-042
MK0991-042
2005_099
Study First Received: February 14, 2006
Last Updated: February 20, 2017

Additional relevant MeSH terms:
Neutropenia
Mycoses
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Caspofungin
Echinocandins
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 21, 2017