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

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

Tracking Information

• First Submitted Date: February 14, 2006
• First Posted Date: February 15, 2006
• Last Update Posted Date: February 23, 2017
• Study Start Date: May 2004
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 23, 2007): Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults. [ Time Frame: 28 Days ]
• Original Primary Outcome Measures (submitted: February 14, 2006): Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.
• Current Secondary Outcome Measures (submitted: December 23, 2007): Caspofungin is generally safe and well tolerated in children 3 to 24 months of age. [ Time Frame: 28 Days ]
• Original Secondary Outcome Measures (submitted: February 14, 2006): Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-042)
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fungal Infection

Intervention

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®

Study Arms

• 1
  IV caspofungin acetate (50 mg/m²/day)
  Intervention: Drug: caspofungin acetate
• 2
  IV caspofungin acetate (70 mg/m²/day)
  Intervention: Drug: caspofungin acetate

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 14, 2006): 16
• Original Enrollment: Same as current
• Actual Study Completion Date: July 2006
• Actual Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 3 Months to 24 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00292071
• Other Study ID Numbers: 0991-042; MK0991-042; 2005_099
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Merck Sharp & Dohme LLC
• Original Responsible Party: Not Provided
• Current Study Sponsor: Merck Sharp & Dohme LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor; Merck Sharp & Dohme LLC

• PRS Account: Merck Sharp & Dohme LLC
• Verification Date: February 2017