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

February 20, 2017 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
IV caspofungin acetate (50 mg/m²/day)
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.
Other Names:
  • MK0991
  • CANCIDAS®
Other: 2
IV caspofungin acetate (70 mg/m²/day)
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.
Other Names:
  • MK0991
  • CANCIDAS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma drug-level observed in children 3 to 24 months of age is similar to the levels observed in adults.
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Time Frame
Caspofungin is generally safe and well tolerated in children 3 to 24 months of age.
Time Frame: 28 Days
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

February 14, 2006

First Submitted That Met QC Criteria

February 14, 2006

First Posted (Estimate)

February 15, 2006

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 20, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0991-042
  • MK0991-042
  • 2005_099

Plan for Individual participant data (IPD)

Study Data/Documents

  1. CSR Synopsis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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