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

NCT00292071 | Completed Phase 2

• 3 other identifiers: 0991-042MK0991-0422005_099
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.

  28 Days

Secondary Outcomes (1)

• Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.

  28 Days

Study Arms (2)

1

OTHER

IV caspofungin acetate (50 mg/m²/day)

Drug: caspofungin acetate

2

OTHER

IV caspofungin acetate (70 mg/m²/day)

Drug: caspofungin acetate

Interventions

caspofungin acetate 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.

Also known as: MK0991, CANCIDAS®

1; 2

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 19114680 BACKGROUND

MeSH Terms

Conditions

Mycoses

Interventions

Caspofungin

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins; Echinocandins; Peptides, Cyclic

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2006
• First Posted: February 15, 2006
• Study Start: May 1, 2004
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: February 23, 2017

Record last verified: 2017-02