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

Pfizer

Status and phase: Completed; Phase 2; Phase 1

Conditions: Neutropenia

Treatments: Drug: Anidulafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00056381

A8851005

VER002-12

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 25 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)