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

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).

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Key information

Conditions

Neutropenia Agranulocytosis Body Temperature Changes Cytopenia Febrile Neutropenia Fever Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukopenia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

2 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Versicor

King of Prussia, Pennsylvania, 19406, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Anidulafungin

Drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

Vicuron Pharmaceuticals

Registry information

Official study title

Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia

Important dates

Study start: 2003
Study completion: 2004
First posted: Mar 12, 2003
Registry last updated: Oct 21, 2008

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