UnknownPhase 1

Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

United States12 participantsStarted 2016-08

Plain-language summary

Ceftaroline fosamil is an intravenous (IV) drug that belongs to a group of antibiotics called cephalosporins . Antibiotics are drugs used to treat infections. Clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. Some of these bacteria may be responsible for infections in the central nervous system.The main aim of this study is to gather information to determine how much of a single IV dose of ceftaroline fosamil will enter into a child's CSF so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

Who can participate

Age range

6 Months – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 6 months - 17 years * Ventriculitis due to VPS infection (abnormal CSF parameters consistent with meningeal inflammation and/or positive CSF culture) * VPS is externalized and External Ventriculostomy Drain (EVD) is in place * Patient has IV access and is receiving antibiotic treatment for VPS infection * Parent/Guardian signed written informed consent * Negative urine or serum pregnancy test for females of child-bearing potential Exclusion Criteria: * Known Allergy to beta-lactam antibiotics * Moderate to severe renal impairment (Creatinine clearance \< 50mL/minute) * Parent/Guardian written consent cannot be obtained * Positive urine or serum pregnancy test

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.

Timeframe: 8 hours

Trial details

NCT IDNCT02600793

SponsorBasim Asmar

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

Contact for this trial

Basim Asmar, MD

313-745-5862 basmar@wayne.edu

View on ClinicalTrials.gov More Cerebrospinal Fluid Shunts trials