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Trials / Completed

CompletedNCT00292071

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
16 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
All
Age
3 Months – 24 Months
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
DRUGcaspofungin 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.

Timeline

Start date
2004-05-01
Primary completion
2006-07-01
Completion
2006-07-01
First posted
2006-02-15
Last updated
2017-02-23

Source: ClinicalTrials.gov record NCT00292071. Inclusion in this directory is not an endorsement.

Open, Pharmacokinetic Study of Caspofungin Acetate in Immunocompromised Young Children With Febrile Neutropenia (0991-04 (NCT00292071) · Clinical Trials Directory