Comparative Evaluation of the Safety & Efficacy of Daptomycin Vs. Standard of Care

Clinical Trial

Offered by: Nemours Children's
Location: Delaware Valley

Trial Name

A Comparative Evaluation of the Safety and Efficacy of Daptomycin Versus Standard of Care in Pediatric Subjects Two - Seventeen Years of Age With Bacteremia Caused by Staphylococcus Aureus

What is the trial about?

This study is looking at the safety, effectiveness, and dosage of an antibiotic call daptomycin in children with blood infections caused by bacteria.

Who can participate?

This study is open to children whose doctors either believe or know for certain that he or she has a blood infection caused by S. aureus, and is between the ages of 2 and 17.

What is involved?

Participation in the study can last from 6 to 9 weeks for children aged 2 to 11 years old and 6 to 11 weeks for children aged 12 to 17 years old, depending on how long the doctor thinks that your child needs to receive antibiotics for his or her infection. While your child is in the hospital, all study related procedures will be done in your child’s hospital room throughout the day. If your child is discharged and will continue receiving IV antibiotics at home, a home care nurse will visit your home to perform study-related procedures. The nurse will be at your home for 1-2 hours. Your child will need to return to the study center on his or her last day of IV treatment, 1 to 2 weeks after the last treatment, and again 3.5 to 5 weeks after last treatment for a final follow-up visit. These visits will last 1-2 hours.

Your child will receive an IV medication every day. Your child will also need to have blood draws and be examined by a member of the research team every day.