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Cephalosporin Antibiotic

Ceftaroline for Cystic Fibrosis

Phase 4

Waitlist Available

Led By Alexander Vinks, PhD

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inpatient

Cystic Fibrosis diagnosis on accepted Cystic Fibrosis Foundation guidelines

Must not have

Less than 2 years old

22 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-hour maximum, single visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing a new way to give the antibiotic ceftaroline to kids with cystic fibrosis who also have a history of methicillin-resistant Staphylococcus aureus (MRSA), also known as oxacillin-resistant Staphylococcus aureus (ORSA).

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Ceftaroline may cause side effects like allergic reactions, gastrointestinal problems (like diarrhea), changes in blood cell counts which can lead to increased risk of infection or bleeding disorders, headache, dizziness, rash or itching.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am currently hospitalized.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 2 years old.

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I am 22 years old or older.

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I do not speak English.

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I weigh less than 15 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-hour maximum, single visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-hour maximum, single visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-hour maximum, single visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ceftaroline Exposure and PK/PD Target Attainment

Secondary study objectives

FEV1 Percentage Change Assessment

Pulmonary Exacerbations

Side Effects

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ceftaroline

2011

Completed Phase 4

~1900

0 / 6Eligibility criteria met