Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
Status:
Completed
Trial end date:
2020-06-16
Target enrollment:
Participant gender:
Summary
This research study is looking at an antibiotic medicine, Ceftaroline Fosamil (Ceftaroline),
which fights infections like the one the subject has. Ceftaroline is effective against
S.aureus germs including those that are called Methicillin Resistant Staphylococcus aureus
(MRSA.)
Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in
adults and children with Community-Acquired Bacterial Pneumonia [a type of lung infection]
and Acute Bacterial Skin and Skin Structure Infections. Ceftaroline is not yet approved for
treatment in subjects with hematogenous osteomyelitis, therefore, the use of Ceftaroline in
this research study is considered "investigational".
The goal of this research study is to find out what side effects there may be when children
are taking Ceftaroline and to study how effective Ceftaroline is in treating bone infections
due to Staphylococcus aureus in children. The investigators are also studying what the body
does to the study drug, Ceftaroline, and if the doses the investigators use result in blood
levels that the investigators think are going to be effective against bone infections in
children. This is called pharmacokinetics (PK).