Clinical Trial: Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase 1/2 Trial of Ceftaroline for the Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Brief 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 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).


Detailed Summary:

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
    Sponsor: Baylor College of Medicine

    Current Primary Outcome: Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), deaths and discontinuations due to adverse events (AEs) [ Time Frame: 1 years ]

    Evaluate the safety of Ceftaroline in pediatric subjects 1 to 17 years of age (inclusive) with acute hematogenous osteomyelitis at the end of intravenous therapy.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Clinical response at the conclusion of IV ceftaroline [ Time Frame: 2 weeks ]
      Clinical response (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) at the end of parenteral therapy (approximately days 5 to 14) by subject and by baseline pathogens although S.aureus is expected to be the predominant pathogen.
    • Clinical outcome at the completion of total therapy (IV ceftaroline plus oral antibiotics) [ Time Frame: 8 weeks ]
      Clinical outcome (site of infection has complete resolution of pain, swelling and warmth, normal erythrocyte sedimentation rate and C-reactive protein level and the patient is able to use the affected extremity normally and is back to normal activities) at the completion of antibiotic treatment (IV ceftaroline plus oral antibiotics).
    • Clinical outcome during the one year follow-up period after end of antibiotic treatment [ Time Frame: 14 months ]
      Clinical outcome (no recurrence of pain, redness, swelling at site of original infection; absence of drainage from surgical wound; absence of pathological fracture; no other evidence of recurrence of infection at the original site of osteomyelitis and the patient is able to use the affected extremity normally and is back to normal activities) during the one year follow-up period.
    • Proportion of participants with plasma levels of Ceftaroline that exceeds 1 μg/mL for over 60% of a dosing interval [ Time Frame: 1 year ]
      The mean and median concentrations of ceftaroline in plasma at the end of infusion will be determined. The proportion of patients with plasma levels of Ceftaroline that exceed 1 μg/mL for over 60% of a dosing interval will be determined.


    Original Secondary Outcome: Same as current

    Information By: Baylor College of Medicine

    Dates:
    Date Received: December 31, 2014
    Date Started: January 2015
    Date Completion: January 2020
    Last Updated: June 24, 2016
    Last Verified: June 2016