Ceftaroline Diffusion Into Cerebrospinal Fluid of Children
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 10/6/2018 |
| Start Date: | August 2016 |
| End Date: | December 2019 |
| Contact: | Basim Asmar, MD |
| Email: | basmar@wayne.edu |
| Phone: | 313-745-5862 |
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.
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.
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.
(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.
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
We found this trial at
1
site
3901 Beaubien St
Detroit, Michigan 48201
Detroit, Michigan 48201
(313) 745-5437
Phone: 313-745-5862
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
Click here to add this to my saved trials
