Recruiting
Phase 1

Ceftaroline Fosamil

Sponsor:

Basim Asmar

Code:

NCT02600793

Conditions

Cerebrospinal Fluid Shunts

Ventriculoperitoneal Shunt

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

Ceftaroline

Study Details

Brief 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.

Conditions

Cerebrospinal Fluid Shunts

Ventriculoperitoneal Shunt

Study ID

NCT02600793

Start date

Aug, 2016

Status verified date

Oct, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1

Single dose IV ceftaroline will be administered

Interventions

Ceftaroline

Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected

Primary outcome measure

  • Pharmacokinetic assessment of Ceftaroline diffusion from blood into the Cerbrospinal fluid. [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Basim Asmar, MD

313-745-5862basmar@wayne.edu

Locations

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Basim Asmar, MD

313-745-5862basmar@wayne.edu

More Information

Sponsor

Basim Asmar

Last update posted

Oct 4, 2018

Last verified

Oct, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Basim Asmar on 2018-10-04.