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Daptomycin in Pediatric Patients With Bacterial Meningitis

This study is currently recruiting participants.
Verified June 2017 by University Hospital Inselspital, Berne
Sponsor:
ClinicalTrials.gov Identifier:
NCT01522105
First Posted: January 31, 2012
Last Update Posted: June 8, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital Inselspital, Berne
  Purpose
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 Intervention Phase
Meningitis Drug: Daptomycin Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

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

Estimated Enrollment: 5
Actual Study Start Date: April 2012
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Show Detailed Description

  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01522105


Contacts
Contact: Philipp Agyeman, MD +41316329487 philipp.agyeman@insel.ch

Locations
Switzerland
Dep. of Pediatrics, University Hospital Bern Recruiting
Bern, Switzerland, 3010
Principal Investigator: Philipp Agyeman, MD         
Sub-Investigator: Christoph Aebi, MD         
Sub-Investigator: Andrea Duppenthaler, MD         
Sub-Investigator: Stephen Leib, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Philipp Agyeman, MD University Children's Hospital Bern
  More Information

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01522105     History of Changes
Other Study ID Numbers: 046/11
2012DR1007 ( Other Identifier: Swissmedic )
2049
First Submitted: January 26, 2012
First Posted: January 31, 2012
Last Update Posted: June 8, 2017
Last Verified: June 2017

Keywords provided by University Hospital Inselspital, Berne:
Meningitis
Central Nervous System Infections
Pediatrics
Daptomycin
Anti-Bacterial Agents
Therapeutic Use
Pharmacologic Actions

Additional relevant MeSH terms:
Meningitis
Meningitis, Bacterial
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Central Nervous System Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents