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Daptomycin in Pediatric Patients With Bacterial Meningitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01522105
Recruitment Status : Terminated (Insufficient patient recruitment)
First Posted : January 31, 2012
Last Update Posted : October 11, 2018
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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 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

Condition or disease Intervention/treatment Phase
Meningitis Drug: Daptomycin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Cerebrospinal Fluid Concentration of Daptomycin (Cubicin¬) in Pediatric Patients With Gram-positive Bacterial Meningitis, Concurrently Receiving Standard Antimicrobial Therapy
Actual Study Start Date : April 2012
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: 1
i.v. daptomycin given 24 hours after first ceftriaxone dose at age appropriate dosage
Drug: Daptomycin
One dose of daptomycin given at an age appropriate dosage (3-24 months 6mg/kg; 2-6 years 10mg/kg; 7-11 years 8mg/kg; 12-16years 6mg/kg)

Primary Outcome Measures :
  1. Characterization of the peak concentration of daptomycin in the cerebrospinal fluid of pediatric patients with bacterial meningitis [ Time Frame: 4-8 hours after drug administration ]

Secondary Outcome Measures :
  1. Evaluate possible side effects of daptomycin in pediatric patients with bacterial meningitis [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01522105

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Dep. of Pediatrics, University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
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Principal Investigator: Philipp Agyeman, MD University Children's Hospital Bern
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Responsible Party: University Hospital Inselspital, Berne Identifier: NCT01522105    
Other Study ID Numbers: 046/11
2012DR1007 ( Other Identifier: Swissmedic )
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by University Hospital Inselspital, Berne:
Central Nervous System Infections
Anti-Bacterial Agents
Therapeutic Use
Pharmacologic Actions
Additional relevant MeSH terms:
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Meningococcal Infections
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Infections
Anti-Bacterial Agents
Anti-Infective Agents