Daptomycin in Pediatric Patients With Bacterial Meningitis

NCT01522105 | Terminated Phase 1

• 3 other identifiers: 046/112012DR10072049
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Meningitis

Keywords

Meningitis; Central Nervous System Infections; Pediatrics; Daptomycin; Anti-Bacterial Agents; Therapeutic Use; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• Characterization of the peak concentration of daptomycin in the cerebrospinal fluid of pediatric patients with bacterial meningitis

  4-8 hours after drug administration

Secondary Outcomes (1)

• Evaluate possible side effects of daptomycin in pediatric patients with bacterial meningitis

  2 years

Study Arms (1)

1

EXPERIMENTAL

i.v. daptomycin given 24 hours after first ceftriaxone dose at age appropriate dosage

Drug: Daptomycin

Interventions

Daptomycin DRUG

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)

1

Eligibility Criteria

• Age: 3 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age \> 3 months and \< 16 years
• Bacterial meningitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Dep. of Pediatrics, University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Meningitis; Central Nervous System Infections

Interventions

Daptomycin

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lipopeptides; Lipids; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Philipp Agyeman, MD

  University Children's Hospital Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2012
• First Posted: January 31, 2012
• Study Start: April 1, 2012
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: October 11, 2018

Record last verified: 2018-10

Locations

CH (1)