Open-Label, Pharmacokinetics Study of Caspofungin in Neonates and Infants

Active, not recruiting

• Conditions: Empirical therapy for fungal infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005032-34-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-27
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patient is <3 months (90 days) of age on day of informed consent.
• Patient has a documented (culture-confirmed) or suspected invasive Candida infection, as defined below.
• Patient must be receiving an intravenous amphotericin B formulation (amphotericin B deoxycholate or lipid preparation of amphotericin B) for the treatment of a highly-suspected or documented invasive Candida infection at the time of study entry and will remain on an intravenous amphotericin B formulation for the duration of caspofungin study therapy.
Are the trial subjects under 18? yes
Number of subjects for this age range: 32
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patient is =3 months (=90 days) of age at the time of informed consent.
• Patient has exclusionary laboratory values as listed below: Hematocrit <35% for patients with a body weight of <1500 grams, AST (SGOT) >2 times the upper limit of normal, for age, ALT (SGPT) >2 times the upper limit of normal, for age.
• Patient is hemodynamically unstable, exhibits hemodynamic compromise, or is not expected to survive at least 5 days.
• Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified