Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: December 7, 2014
Last verified: December 2014

February 14, 2006
December 7, 2014
May 2004
July 2006   (final data collection date for primary outcome measure)
Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.
Complete list of historical versions of study NCT00292071 on ClinicalTrials.gov Archive Site
Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ] [ Designated as safety issue: Yes ]
Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
Not Provided
Not Provided
 
Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Fungal Infection
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®
  • 1
    IV caspofungin acetate (50 mg/m²/day)
    Intervention: Drug: caspofungin acetate
  • 2
    IV caspofungin acetate (70 mg/m²/day)
    Intervention: Drug: caspofungin acetate
Neely M, Jafri HS, Seibel N, Knapp K, Adamson PC, Bradshaw SK, Strohmaier KM, Sun P, Bi S, Dockendorf MF, Stone JA, Kartsonis NA. Pharmacokinetics and safety of caspofungin in older infants and toddlers. Antimicrob Agents Chemother. 2009 Apr;53(4):1450-6. doi: 10.1128/AAC.01027-08. Epub 2008 Dec 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2006
July 2006   (final data collection date for primary outcome measure)

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.
Both
3 Months to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00292071
0991-042, MK0991-042, 2005_099
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP