Japanese Children & Adolescents New Onset Fever & Neutropenia

• Conditions: Candida or Aspergillus Infections; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004910-27-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-24
• Last Update Posted: 2 March 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female Japanese patient between the ages of 3 months and 17 years at the time when informed consent was obtained.
• Patients in whom a causative fungus was detected before treatment with the study drug or patients with strongly suspected Candida or Aspergillus infections, as defined below for esophageal candidiasis, invasive candidiasis (candidemia or other types of invasive candidiasis), and aspergillosis (invasive aspergillosis, chronic necrotizing pulmonary aspergillosis, or pulmonary aspergilloma).

Are the trial subjects under 18? yes
Number of subjects for this age range: 20
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

• Patients with mycoses (e.g., Cryptococcus spp., Trichosporon spp., or zygomycetes including Mucor spp.) other than ones due to Candida spp. or Aspergillus spp.
• Patients who will receive other systemic antifungal agents (indicated for deep-seated fungal infections) for the first time in the screening period.
• At screening, patients with any of the laboratory abnormalities listed below: (1) Total bilirubin: More than 5 times the upper limit of the normal range (>5 ULN), (2) AST (SGOT) or ALT (SGPT): More than 5 times the upper limit of the normal range (>5 ULN)

Study & Design

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