Daptomycin in Pediatric Patients With Bacterial Meningitis
This study is currently recruiting participants.
Verified May 2013 by University Hospital Inselspital, Berne
Sponsor:
University Hospital Inselspital, Berne
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT01522105
First received: January 26, 2012
Last updated: May 23, 2013
Last verified: May 2013
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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:
MedlinePlus related topics:
Meningitis
Drug Information available for:
Daptomycin
U.S. FDA Resources
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: | July 2014 |
| Estimated Primary Completion Date: | January 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: 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
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: | May 23, 2013 |
| Health Authority: | Switzerland: Independent Local Research Ethic Commission (Ethikkommission) Switzerland: Swiss Agency for therapeutic products (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 June 18, 2013