CompletedPhase 1

Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

United States84 participantsStarted 2007-10-14

Plain-language summary

Children with fungal infections will be divided into two groups by weight. Children weighing \< 25 kg will receive a higher dose of study medication (per kg body weight) for 10 to 14 days than children weighing \> 25 kg.

Who can participate

Age range2 Years – 16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is 2 to 16 years inclusive
✓. Subject has suspected, proven or probable candidiasis, candidemia or other invasive candidiasis
✓. Subject has sufficient venous access to permit administration of study medication, collection of pharmacokinetic samples, and monitoring of laboratory safety variables

Exclusion criteria

✕. Subject has evidence of significant liver disease, as defined by aspartate transaminase (AST), alanine transaminase (ALT), bilirubin or alkaline phosphatase \> 5 times the upper limit of normal (ULN)
✕. Subject has a concomitant medical condition that in the opinion of the investigator and/or medical monitor precludes enrollment into the study
✕. Subject has a history of anaphylaxis, hypersensitivity, or any serious reaction to the echinocandin class of antifungals
✕. Subject has received treatment with an echinocandin within one week prior to first dosing
✕. Subject status is unstable and subject is unlikely to complete all study required procedures

What they're measuring

PK parameters (AUCtau, Tmax, and Cmax)

Timeframe: 10 - 14 Days

Trial details

NCT IDNCT00608335

SponsorAstellas Pharma Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2011-09-08

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