Trial Outcomes & Findings for Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children (NCT NCT02335905)

Last Updated: 2021-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

11 participants

Primary outcome timeframe

Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration.

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	Ceftaroline Fosamil 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. 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).
Overall Study STARTED	11
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ceftaroline Fosamil n=11 Participants 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. 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).
Age, Categorical <=18 years	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	10.7 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Race/Ethnicity · Non Hispanic	5 Participants n=5 Participants
Race/Ethnicity, Customized Number analyzed · Hispanic	6 Participants n=5 Participants
Race/Ethnicity, Customized Number analyzed · Non Hispanic	5 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants
Number of participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration.

Population: One patient never received ceftaroline after enrollment because his bone biopsy showed histiocytosis.

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.

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil n=11 Participants 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. 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)	1 incidence

SECONDARY outcome

Timeframe: 2 weeks

Population: 10 patients who received 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.

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil n=10 Participants 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. 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).
Clinical Response at the Conclusion of IV Ceftaroline	7 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil n=10 Participants 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. 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).
Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics)	7 Participants

SECONDARY outcome

Timeframe: 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 which occurred approximately 14 month after enrollment and 12 months after completing antibiotic treatment.

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil n=10 Participants 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. 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).
Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment.	7 Participants

SECONDARY outcome

Timeframe: Blood for ceftaroline levels could be obtained once on study day 2 through day 5 post infusion of a dose of ceftaroline.

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.

Outcome measures

Outcome measures
Measure	Ceftaroline Fosamil n=10 Participants 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. 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).
Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval	10 Participants

Adverse Events

Ceftaroline Fosamil

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ceftaroline Fosamil n=11 participants at risk 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. 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).
Infections and infestations progression of infection	9.1% 1/11 • Number of events 1 • 14 months

Other adverse events

Adverse event data not reported

Additional Information

Sheldon L. Kaplan

Baylor College of Medicine

Phone: 832-824-4330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place