A Phase 1/2 interventional study of Ceftaroline Fosamil in Hematogenously Acquired Staphylococcus Aureus Osteomyelitis, Bone Infection and Osteomyelitis, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Baylor College of Medicine · Phase 1/2, Interventional, and Treatment
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).
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:
273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.
This study's enrollment of 11 is below the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.
Browse Staphylococcal Infections studies →Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) have results posted.
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Exclusion Criteria:
IV Ceftaroline fosamil 15 mg/kg (or 600 mg if \> 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour). The dose may vary with age.
Drug: Ceftaroline Fosamil
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).
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.
Time frame: Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration.
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.
Time frame: 2 weeks
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).
Time frame: 8 weeks
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.
Time frame: 14 months
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.
Time frame: Blood for ceftaroline levels could be obtained once on study day 2 through day 5 post infusion of a dose of ceftaroline.
| Milestone | Ceftaroline Fosamil |
|---|---|
| Started | 11 |
| Completed | 7 |
| Not completed | 4 |
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.
| incidence | Ceftaroline Fosamil |
|---|---|
| Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) | 1 |
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.
| Participants | Ceftaroline Fosamil |
|---|---|
| Clinical Response at the Conclusion of IV Ceftaroline | 7 |
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).
| Participants | Ceftaroline Fosamil |
|---|---|
| Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) | 7 |
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.
| Participants | Ceftaroline Fosamil |
|---|---|
| Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. | 7 |
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.
| Participants | Ceftaroline Fosamil |
|---|---|
| Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval | 10 |
Collected over 14 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ceftaroline Fosamil | 0/11 (0%) | 1/11 (9.1%) | 0/11 (0%) |
| Event | Ceftaroline Fosamil |
|---|---|
| progression of infectionInfections and infestations | 1/11 |
| Age, Categorical(Participants) | Ceftaroline Fosamil |
|---|---|
| <=18 years | 11 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(years) | Ceftaroline Fosamil |
|---|---|
| Median | 10.7 (2.3 to 12) |
| Sex: Female, Male(Participants) | Ceftaroline Fosamil |
|---|---|
| Female | 2 |
| Male | 9 |
| Ethnicity (NIH/OMB)(Participants) | Ceftaroline Fosamil |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 5 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | Ceftaroline Fosamil |
|---|---|
| Race/Ethnicity — Hispanic | 6 |
| Race/Ethnicity — Non Hispanic | 5 |
| Number analyzed — Hispanic | 6 |
| Number analyzed — Non Hispanic | 5 |
| Region of Enrollment(Participants) | Ceftaroline Fosamil |
|---|---|
| United States | 11 |
| Number of participants(Participants) | Ceftaroline Fosamil |
|---|---|
| Count of participants | 11 |
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