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

NCT ID: NCT00292071

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2006-07-31

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.

Conditions

Fungal Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

IV caspofungin acetate (50 mg/m²/day)

Group Type: OTHER

caspofungin acetate

Intervention Type: DRUG

(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.

2

IV caspofungin acetate (70 mg/m²/day)

Group Type: OTHER

caspofungin acetate

Intervention Type: DRUG

(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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

MK0991; CANCIDAS®

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: BACKGROUND

PMID: 19114680 (View on PubMed)

Study Documents

Document Type: CSR Synopsis

View Document

Other Identifiers

MK0991-042

Identifier Type: -

Identifier Source: secondary_id

2005_099

Identifier Type: -

Identifier Source: secondary_id

0991-042

Identifier Type: -

Identifier Source: org_study_id