Daptomycin in Pediatric Patients With Bacterial Meningitis

• Status: Terminated
• Trial end date: 2018-06-30
• Target enrollment: 0
• Participant gender: All

Summary

5 Children > 3months and < 16 years with Gram-positive meningitis will receive a single dose of daptomycin 24 hours after the first dose of ceftriaxone. 4-8 hours after daptomycin administration a second lumbar puncture is performed to determine the peak concentration of daptomycin in the cerebrospinal fluid. In parallel peak and trough level of daptomycin will be measured in the plasma. The investigators anticipate that daptomycin penetrates into the cerebrospinal fluid in bactericidal concentrations

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Daptomycin

Criteria

Inclusion Criteria:

• Age > 3 months and < 16 years

• Bacterial meningitis

• Written parental (or appropriate legal representative) informed consent prior to study inclusion

Exclusion Criteria

• Gram-negative bacteria in the CSF

• Creatinine clearance < 80ml/min/1.73m2

• Creatinine phosphokinase level > 2x upper age related norm

• Known allergy or hypersensitivity to daptomycin

• Known clinical significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, endocrine, hematologic, autoimmune disease, or primary immunodeficiency

• Height and weight below 3rd or above 95th percentile

• History of, or current muscular disease

• Underlying neurological disease with disruption of blood brain barrier

• Epilepsy

• Muscular weakness, history of peripheral neuropathy, or Guillain-Barré syndrome