Research

Candidiasis Treatment with Anidulafungin

A Study to Assess the Pharmacokinetics, Safety and Efficacy of Anidulafungin When Used to Treat Children with Invasive Candidiasis, Including Candidemia

Protocol Description

This multicenter study is being done to learn more about the drug anidulafungin when given for the treatment of candidiasis, a fungal infection caused by the Candida species (yeasts). Infections range from superficial, such as oral thrush and vaginitis, to systemic, which is referred to as candidemia and can be life-threatening. Invasive infections of this type almost always occur in people who have low immune system function due to cancer, human immunodeficiency virus (HIV), chemotherapy, organ translant, and use of steroids among other reasons. This medicine has been approved for treatment of this type of fungal infection in adults, but has not yet been approved for use by children.

Eligibility Criteria

Subject to certain exclusion criteria, this study is open to infants, children and teens through age 17, who have been diagnosed as having an infection caused by the fungus Candida.
Males and Females: Ages 1 month through 17 years

Requirements
Following screening examination, participants’ treatment will require daily intravenous (IV) administration of the study drug for a minimum of 10 days and a maximum of 35. After 10 days, the study doctor may optionally switch treatment to oral therapy with fluconazole. Follow-up visits will occur at 2 and 6 weeks.
Visits: Most participants will be treated while in the hospital, but some may be able to complete study medication on an outpatient basis, as determined by the study doctor.
Duration: 6 weeks

Status: Open for Enrollment

Source(s) of Support
Pfizer

Additional Information
Study description at National Institutes of Health