Study To Assess Pharmacokinetics, Safety & Efficacy of Anidulafungin When Treating Children With Invasive Candidiasis

• Status: Completed
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Prospective, open label study to assess the pharmacokinetics, safety & efficacy of anidulafungin when used to treat children (aged 1 month - <18 years) with invasive candidiasis, including candidemia (ICC).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Anidulafungin; Echinocandins; Fluconazole

Criteria

Inclusion Criteria:

• Subject must be either (1) at high risk for candidiasis (1 month - < 2 years ONLY) or (2) have a definitive diagnosis of invasive candidiasis/candidemia (ICC) (All age groups)

• Male and female patients from 1 month to less than 18 years of age.

Exclusion Criteria:

• Any patients with allergy to the drug; and any pregnant female or lactating.

• Failed previous antifungal therapy or expected to live < 3 days.

• Patients with documented or suspected Candida meningitis.