Status:
TERMINATED
Daptomycin in Pediatric Patients With Bacterial Meningitis
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Meningitis
Eligibility:
All Genders
3-16 years
Phase:
PHASE1
Brief 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 s...
Detailed Description
Background Acute bacterial meningitis is a severe infection, which leads to persistent neurological deficits in up to 50% of patients, despite optimal medical treatment. Although, the incidence of ac...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT01522105
Start Date
April 1 2012
End Date
June 30 2018
Last Update
October 11 2018
Active Locations (1)
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1
Dep. of Pediatrics, University Hospital Bern
Bern, Switzerland, 3010