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Ceftaroline Diffusion Into Cerebrospinal Fluid of Children

NCT02600793 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-10-04

No results posted yet for this study

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

Interventions

DRUG

Ceftaroline

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

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Basim Asmar

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02600793 on ClinicalTrials.gov