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
Ceftaroline has been approved by the U.S. Food and Drug Administration (FDA) for use in
adults with Community-Acquired Bacterial Pneumonia [a type of lung infection] and Acute
Bacterial Skin and Skin Structure Infections. Ceftaroline has been studied in children with
both simple and complicated pneumonia but the FDA has not yet approved Ceftaroline for use
in subjects less than 18 years of age. 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).
This is a Phase 1/2, open-label, single-center study to determine safety and tolerability of
Ceftaroline in pediatric subjects 1 to 17 years of age (inclusive) with signs and symptoms
of acute hematogenous osteomyelitis at the end of intravenous therapy. After informed
consent/assent is obtained, Ceftaroline will be administered intravenously. After the
subject has been afebrile for at least 48 hours, has negative blood cultures, is clearly
improving in general, is able to eat and drink, and is able to use or move the involved
extremity, the subject may be switched to oral antibiotic administration.
The duration of subject participation from signing the informed consent form will be up to
14 months [(includes screening period (1 Day), study IV drug administration (approximately
2-14 Days), Standard of Care Oral Drug Administration (4-5 weeks) (the total maximum
treatment period is typically 6 weeks), and a follow-up visit 12 months after the last dose
of study drug)]. Baseline assessments for study eligibility will occur within 24 hours
before the first dose of study drug. A minimum of 2 days (48 hours) of study drug
administration is required.
Some of the tests and procedures completed during this study may be part of regular care for
the subject's condition. Some tests and procedures will be done only for study purposes.
Some regular procedures may also be completed more often as part of the research study.
1. Past and Current Medical History: A detailed review of the subject's medical history,
including demographics, concomitant medication review, medical/surgical history will be
2. Vital Signs: Weight, height, blood pressure, pulse rate, and body temperature, will be
3. Physical Exam: Physical exam will include, evaluation of subject's overall health,
examination site of infection, and assessment of subject's ability to move affected
4. Safety Laboratory Assessments: Routine laboratory monitoring including liver function
tests will be done 24 hours prior to enrollment and weekly during Ceftaroline
treatment, and the completion of Ceftaroline treatment and at the follow-up visit.
Isolate susceptibility testing will be done at baseline visit.
5. Pregnancy testing: For females of child-bearing potential, urine pregnancy will be
performed prior to and after completing antibiotic treatment.
6. Pharmacokinetics Assessment: One PK blood sample will be obtained from all subjects who
receive Ceftaroline fosamil.
- Informed consent in writing from parent(s) or other legally acceptable
representative(s) and assent from subject (if appropriate according to local
- Male or female 1 to 17 years of age, inclusive.
- Suspected hematogenous S.aureus osteomyelitis in a large bone (upper or lower
extremities, pelvis) based on clinical findings and radiology results.
- One to three site(s) of osteomyelitis with expectation that transition to oral
antibiotics from IV therapy will be likely prior to discharge to complete antibiotic
therapy. The second or third site might be contiguous like a proximal tibia and
distal femur but could also be at sites unrelated such as a distal femur and pelvic
- Female subjects who have reached menarche must have a negative urine pregnancy test.
- Female subjects who have reached menarche and are sexually active must be willing to
practice sexual abstinence or dual methods of birth control during treatment and for
at least 28 days after the last dose of any study drug.
- Sufficient IV access to receive medication.
- Received more than 24 hours of IV antibiotics prior to enrollment
- More than one bone infected
- Disseminated infection or is admitted to the pediatric intensive care unit
- Underlying condition (excludes mild eczema or reactive airways disease)
- Suspected venous thrombosis or concern for endocarditis
- Requirement for other reasons for another antibiotic potentially active against
organisms commonly causing osteomyelitis in children.
- Creatinine clearance less than 50 mL/min/1.73m2 (calculated by the Schwartz formula)
- Liver transaminases greater than 3 times the upper limit of normal
- Neutropenia (less than 500 neutrophils/mm^3
- Thrombocytopenia (less than 50,000 platelets/mm^3)
- Females who are currently pregnant or breast feeding
- Hypersensitivity reaction to any Beta-lactam antibiotic
- Has had an allergic reaction to ceftaroline in the past