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

Fungal Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00292071
• Other study ID #: 0991-042
• Secondary ID: MK0991-0422005_0
• Status: Completed
• Phase: Phase 2
• First received: February 14, 2006
• Last updated: February 20, 2017
• Start date: May 2004
• Est. completion date: July 2006

Study information

• Verified date: February 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses
• Neutropenia

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.		28 Days
Secondary	Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.		28 Days