Cerebrospinal Fluid ShuntsPhase 1NCT02600793
Ceftaroline Diffusion Into Cerebrospinal Fluid of Children
A Phase 1 study testing Ceftaroline in people with Cerebrospinal Fluid Shunts and Ventriculoperitoneal Shunt, run by Basim Asmar at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Cerebrospinal Fluid Shunts, Ventriculoperitoneal Shunt
- What is being tested?
- Ceftaroline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Basim Asmar, MD, 313-745-5862, basmar@wayne.edu
About this study
Official title: Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection
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.
Read the detailed description
Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.
- Being tested
- Ceftaroline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CeftarolineDrug
Also called Ceftaroline Fosamil, Teflaro
Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Single dose IV ceftaroline will be administered Receives: Drug: Ceftaroline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.
Serial collection of three blood and three cerbrospinal fluid sample over 8 hours
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startAug 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrospinal Fluid ShuntsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basim Asmar
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Basim Asmar, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600793
- Sponsor's protocol ID
- CeftarolineCSF2013
- Status last verified
- Oct 2018
- First submitted
- 6 Nov 2015
- Last updated
- 4 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ceftaroline Diffusion Into Cerebrospinal Fluid of Children With Ventriculitis Due to Ventriculoperitoneal Shunt (VPS) Infection
- ClinicalTrials.gov ID
- NCT02600793
- Acronym / sponsor ID
- CeftarolineCSF2013
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Basim AsmarUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Aug 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 9 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children 6 months to 17 years of age admitted to the hospital because of infected VPS (ventriculitis) will be eligible for the study. A total of twelve eligible patients will be included in the study. Eligible study subjects would be patients who have undergone VPS removal and placement of EVD tubing and are being treated with standard IV antibiotics for ventriculitis. CSF cultures are obtained before antibiotics treatment is initiated. Standard initial antibiotics regimen is usually IV ceftriaxone and vancomycin. The antibiotics regimen is subsequently adjusted based on the pathogen recovered from the CSF culture. Total IV antibiotic treatment is usually 14 days. Following clearance of the infection the patient undergoes new VPS insertion by neurosurgery service.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: CeftarolineSingle dose IV ceftaroline will be administered |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CeftarolineAlso: Ceftaroline Fosamil, TeflaroFollowing Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected | Drug | Arm 1 |
Primary outcome
Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid.
Time frame: 8 hours
Serial collection of three blood and three cerbrospinal fluid sample over 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
Related trials for Cerebrospinal Fluid Shunts
Not yet recruiting
A Prospective Study Comparing CSF Shunt Flow Between "Virtual Off" and "Flow Permissive" Shunt Valve Settings Using a Wireless, Noninvasive Shunt Flow Sensor
Hydrocephalus
Recruiting
Assessment of CSF Shunt Flow During Activities of Daily Living and Sleep With a Thermal Measurement Device
Hydrocephalus
Recruiting
Cefazolin Antibiotic Prophylaxis in Ventricular Shunt Surgery: Determination of Cerebrospinal Fluid Concentration During Valve Implantation
Hydrocephaly, CSF Shunts
Not yet recruiting
Study of Shunt Flow Under Different Valve Settings Using a Wireless Sensor
Hydrocephalus
Not yet recruitingObservational study
Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ceftaroline in people with Cerebrospinal Fluid Shunts and Ventriculoperitoneal Shunt, run by Basim Asmar at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Basim Asmar, MD (313-745-5862, basmar@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid. (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.