Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
Condition: Hematogenously Acquired Staphylococcus Aureus Osteomyelitis; Bone Infection; Osteomyelitis
MeSH terms: Staphylococcal Infections; Osteomyelitis
Study type: Interventional
Phase: Phase 1/Phase 2

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).
    

Detailed description: 
      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.

      Study assessments:

        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
           performed.

        2. Vital Signs: Weight, height, blood pressure, pulse rate, and body temperature, will be
           recorded.

        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
           limb.

        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.
    

Intervention name(s): Ceftaroline Fosamil
Intervention type(s): Drug
Intervention description(s): IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive).
Intervention MeSH terms: Ceftaroline fosamil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment