Ceftaroline for Cystic Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen byAlexander Vinks, PhD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Children's Hospital Medical Center, Cincinnati

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is an open-label, single center, prospective study of patients with a diagnosis of cystic fibrosis (CF) and a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus aureus (ORSA), being treated with intravenous ceftaroline. Patients will have intravenous ceftaroline dosed according to current recommendations based upon its approved usage in pediatric patients for community acquired pneumonia. The investigators will analyze pharmacokinetic (PK) and pharmacodynamic (PD) data using serum concentrations of ceftaroline measured at various time-points following infusion of ceftaroline to develop PK/PD guided dosing strategies of ceftaroline in pediatric CF patients that would be tailored to account for bacterial susceptibility and disease progression.

Research Team

Alexander Vinks, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Eligibility Criteria

This trial is for children and teens with cystic fibrosis who have had infections caused by a tough-to-treat bacteria called MRSA. They must be in the hospital, weigh at least 15 kg, and their liver tests need to be within certain limits. The study excludes very young kids under 2 years old, adults over 22, those with severe liver issues or low platelets, patients without confirmed CF diagnosis, and non-English speaking families.

Inclusion Criteria

I am currently hospitalized.

My doctor has decided to treat me with intravenous ceftaroline.

I have been diagnosed with Cystic Fibrosis according to the foundation's guidelines.

Exclusion Criteria

Your liver enzymes (AST or ALT) are more than 5 times the normal level.

I am under 2 years old.

Your platelet count is less than 50,000.

See 6 more

Treatment Details

Interventions

Ceftaroline (Cephalosporin Antibiotic)

Trial OverviewThe study is testing how the drug Ceftaroline works in the bodies of kids and teens with cystic fibrosis when given through an IV. It looks at how much of the drug gets into the bloodstream and how it fights bacteria. This will help figure out the best doses that match up with disease severity and bacterial resistance.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: PK/PDExperimental Treatment1 Intervention

Open-label prospective study with participants receiving treating physician-approved intravenous ceftaroline, dosed according to current recommendations. Blood samples collected at baseline, 1 hour, 1.5 hours, 3 hours, and 6 hours after infusion.

Ceftaroline is already approved in Canada for the following indications: