Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2004-06-30

Brief Summary

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Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Detailed Description

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Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Conditions

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Neutropenia

Keywords

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neutropenia fever febrile neutropenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anidulafungin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children ages 2-17 years with fever and neutropenia.
* The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Pfizer, Inc.

Locations

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Versicor

King of Prussia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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A8851005

Identifier Type: -

Identifier Source: secondary_id

VER002-12