Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT02335905
Eligibility Criteria:
Inclusion Criteria:
* Informed consent in writing from parent(s) or other legally acceptable representative(s) and assent from subject (if appropriate according to local requirements)
* 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 bone.
* 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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
17 Years
Study:
NCT02335905
Study Brief:
Protocol Section:
NCT02335905