Comparison Amphotericin B Liposome Neutropenic Pediatric Patients

• Conditions: Empirical Therapy in Pediatric Patients; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-005021-13-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: 100

Inclusion Criteria

• Male or female patients are at least 2 years of age and less than 18 years of age at the time of initial screening.
• Patient has received chemotherapy for leukemia, lymphoma, or other cancers or has undergone hematopoietic stem-cell transplantation.
• Patient has had an absolute neutrophil count <500/µL for at least 96 hours (the patient must not be expected to recover from neutropenia in the next 48 hours), and has received at least 96 hours of parenteral broad spectrum systemic antibacterial therapy preceding randomization, and has fever >38.0°C within the last 24 hours prior to randomization. Appropriate antibiotics are those that provide broad spectrum Gram-positive and Gramnegative coverage.

Are the trial subjects under 18? yes
Number of subjects for this age range: 82
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 has an inadequately managed bacterial infection at the time of enrollment.
• Patient has abnormal laboratory values: 1) Platelet count <5000/µL. 2) INR >1.6 (if patients are receiving anticoagulants, INR>4.0). 3) Bilirubin >3 times upper limit of normal for age. 4) AST (SGOT) or ALT (SGPT) >5 times the upper limit of normal for age.
• Patient has a known documented invasive fungal infection at the time of enrollment.

Study & Design

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