Study of CANCIDAS in Children types of ungal infections

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

• Registration Number: EUCTR2014-004911-35-Outside-EU/EEA
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-03
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

The patient is at least 3 months of age and younger than 18 years of age at time of study drug administration.
Clinical evidence of infection must be present at some time within 48 hours prior to enrollment.
Inclusion Criteria for Patients With Aspergillus Infections: 1) Patients must meet definitions of proven or probable invasive aspergillosis (as specified in criteria developed by the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Co- Operative Group (EORTC/IFICG) and the National Institute of Allergy and Infectious Diseases - Mycoses Study Group (NIAID-MSG)
Inclusion Criteria for Patients With Esophageal Candida Infections, Patients with a diagnosis of esophageal candidiasis based on symptoms, endoscopy and microbiology or histopathology for whom IV therapy is appropriate.
Inclusion Criteria for Patients With Invasive Candida Infections, Patient must have at least 1 positive culture of a Candida species from blood or other normally sterile body site, which has been obtained within 4 days of study entry.

Are the trial subjects under 18? yes
Number of subjects for this age range: 49
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 or =18 years of age (at time of the first dose of study drug administration).
Patient has any of the following abnormal laboratory values: a) International normalization ratio (INR) >1.6 or, if patient is receiving anticoagulants, INR >4.0. b) Bilirubin >3 times the upper limit of normal for age. c) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age. d) Platelet count <5000/µL.

Study & Design

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