Osteomyelitis Clinical Trial
Official title:
Phase 1/2 Trial of Ceftaroline for the Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children
Verified date | October 2021 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 11 |
Est. completion date | June 16, 2020 |
Est. primary completion date | June 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) | 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. | Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration. | |
Secondary | Clinical Response at the Conclusion of IV Ceftaroline | 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. | 2 weeks | |
Secondary | Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) | 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). | 8 weeks | |
Secondary | Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. | 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 which occurred approximately 14 month after enrollment and 12 months after completing antibiotic treatment. | 14 months | |
Secondary | Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 µg/mL for Over 60% of a Dosing Interval | 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. | Blood for ceftaroline levels could be obtained once on study day 2 through day 5 post infusion of a dose of ceftaroline. |
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