NCT02335905

Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

Completed Phase 1, PHASE2 Results posted Last updated 2 November 2021

What this trial tests

Phase 1, PHASE2 trial testing Ceftaroline Fosamil in Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in 11 participants. Completed in 16 June 2020.

Timeline

3 June 2015

Primary endpoint
16 June 2020

16 June 2020

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	3 June 2015
Primary completion	16 June 2020
Estimated completion	16 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Ceftaroline Fosamil (CEFTAROLINE) — full drug profile →

Conditions studied

• Hematogenously Acquired Staphylococcus Aureus Osteomyelitis — all drugs for Hematogenously Acquired Staphylococcus Aureus Osteomyelitis →
• Bone Infection — all drugs for Bone Infection →
• Osteomyelitis — all drugs for Osteomyelitis →

Sponsor

Baylor College of Medicine

Who can join

Adults 1 to 17, any sex, with Hematogenously Acquired Staphylococcus Aureus Osteomyelitis or Bone Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths and Discontinuations Due to Adverse Events (AEs) Primary · Predose and every 8 hours up to a maximum of 14 days for ceftaroline administration.

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.

Group	Value	95% CI
Ceftaroline Fosamil	1

Clinical Response at the Conclusion of IV Ceftaroline Secondary · 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.

Group	Value	95% CI
Ceftaroline Fosamil	7

Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics) Secondary · 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).

Group	Value	95% CI
Ceftaroline Fosamil	7

Clinical Outcome During the One Year Follow-up Period After End of Antibiotic Treatment Which is Approximately 14 Months After Enrollment. Secondary · 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.

Group	Value	95% CI
Ceftaroline Fosamil	7

Proportion of Participants With Plasma Levels of Ceftaroline That Exceeds 1 μg/mL for Over 60% of a Dosing Interval Secondary · 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.

Group	Value	95% CI
Ceftaroline Fosamil	10

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ceftaroline Fosamil

Serious: 1/11 (9%)

Deaths: 0/11

Serious adverse events (1 terms)

Reaction	System	Ceftaroline Fosamil
progression of infection	Infections and infestations	—

Most-reported serious reactions: progression of infection.

Data from ClinicalTrials.gov NCT02335905 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implantable antimicrobial biomaterials for local drug delivery in bone infection models.
   Caplin JD, García AJ. · · 2019 · cited 67× · PMID 30654212 · DOI 10.1016/j.actbio.2019.01.015