Ceftaroline for Treatment of Hematogenously Acquired Staphylococcus Aureus Osteomyelitis in Children

NCT02335905 | Completed Phase 1 Results DMC

• 2 other identifiers: H-35130TEF-IT-43/IIT-2017-10048
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Hematogenously Acquired Staphylococcus Aureus Osteomyelitis; Bone Infection; Osteomyelitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical Response at the Conclusion of IV Ceftaroline

  2 weeks

• Clinical Outcome at the Completion of Total Therapy (IV Ceftaroline Plus Oral Antibiotics)

  8 weeks

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

  14 months

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

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

Study Arms (1)

Ceftaroline Fosamil

EXPERIMENTAL

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

Interventions

Ceftaroline Fosamil DRUG

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).

Ceftaroline Fosamil

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Allergan: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Links

• Physician Profile

MeSH Terms

Conditions

Osteomyelitis

Interventions

Ceftaroline

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Sheldon L. Kaplan
• Organization: Baylor College of Medicine

skaplan@bcm.edu

832-824-4330

Study Officials

• Sheldon L. Kaplan, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 12, 2015
• Study Start: June 3, 2015
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Locations

US (1)