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

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.

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Key information

Conditions

Fungal Infection Bacterial Infections and Mycoses Infections Mycoses

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: MK0991, CANCIDAS®

Primary outcomes

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

Time frame: 28 Days

Secondary outcomes

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

Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2006
First posted: Feb 15, 2006
Registry last updated: Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed