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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-hour maximum, single visit

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am currently hospitalized.

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ceftaroline Exposure and PK/PD Target Attainment

Secondary outcome measures

FEV1 Percentage Change Assessment

Pulmonary Exacerbations

Side Effects

+1 more

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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,572 Total Patients Enrolled

22 Trials studying Cystic Fibrosis

1,161 Patients Enrolled for Cystic Fibrosis

Alexander Vinks, PhDPrincipal InvestigatorChildren's Hospital Medical Center, Cincinnati

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any enrolling opportunities still available for participants in this research?

"This particular clinical trial, as indicated by the website clinicaltrials.gov, is not presently looking for patients to enroll. However, 437 other medical studies are currently recruiting individuals."

Answered by AI

How many people are being recruited for this research project?

"Currently, this trial is not searching for new participants. The original posting date was September 1st, 2017 and the most recent update to the listing was on August 29th, 2022. For patients looking for similar studies, there are 433 clinical trials enrolling patients with cystic fibrosis and 4 different trials testing this treatment that are actively recruiting."

Answered by AI

Does this research require participants to be a certain age?

"The target age range for patients in this study are those that have turned 2 years old, but are not yet 21."

Answered by AI

Can you tell me about any other research that has been conducted on this therapy?

"Currently, 4 clinical trials are underway with 1 in Phase 3. These global studies are being conducted at 329 different locations, with a significant portion taking place in Morgantown, West virginia."

Answered by AI