Trial record 2 of 337 for:    meningitis

Daptomycin in Pediatric Patients With Bacterial Meningitis

This study has suspended participant recruitment.
(Sponsor is abroad for a year)
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01522105
First received: January 26, 2012
Last updated: March 3, 2014
Last verified: March 2014
  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
Gram-Positive Bacteria
Drug: Daptomycin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate possible side effects of daptomycin in pediatric patients with bacterial meningitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 2015 (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

Ages Eligible for Study:   3 Months to 16 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522105

Locations
Switzerland
Dep. of Pediatrics, University Hospital Bern
Bern, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Philipp Agyeman, MD University Children's Hospital Bern
  More Information

No publications provided

Responsible Party: Philipp Agyeman, MD, University Hospital Bern
ClinicalTrials.gov Identifier: NCT01522105     History of Changes
Other Study ID Numbers: 046/11, 2012DR1007, 2049
Study First Received: January 26, 2012
Last Updated: March 3, 2014
Health Authority: Switzerland: Ethikkommission
Switzerland: Swissmedic

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 Infections
Central Nervous System Diseases
Nervous System Diseases
Central Nervous System Bacterial Infections
Bacterial Infections
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014