An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Astellas

Status and phase: Completed; Phase 1

Conditions: Candida

Treatments: Drug: Micafungin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818584

9463-CL-2104

Details and patient eligibility

About

This study will evaluate pharmacokinetics and safety of intravenous micafungin in neonates with suspected candida infection

Full description

Subjects will be stratified by weight to receive one of two doses of study drug

Enrollment: 13 patients

Sex: All

Ages: 48 hours to 120 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent and HIPAA authorization of the infant's parent or legally authorized representative must be obtained prior to study entry
• Infant has sufficient venous access to permit study drug dosing
• Infant is suspected to have a systemic Candida infection and appropriate cultures (blood with or without urine/CSF) are obtained at the time of study entry

Exclusion criteria

• Infant has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
• Infant has received an echinocandin within one month prior to study entry
• Infant has a concomitant medical condition which, in the opinion of the investigator and/or medical advisor, may create an unacceptable additional risk
• Infant has a life expectancy of less than 96 hours

Trial design

13 participants in 2 patient groups

1. micafungin lower dose

Experimental group

Treatment:

Drug: Micafungin

2. micafungin higher dose

Experimental group

Treatment:

Drug: Micafungin