Daptomycin at high dose for hemodialysis patient
Early Phase 1
- Conditions
- Catheter related blood stream infection.Catheter-related bloodstream infection (CRBSI)T80-211
- Registration Number
- IRCT2016101730345N1
- Lead Sponsor
- CHU de Poitiers
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
Inclusion: patients > 18 years, requiring conventional hemodialysis for chronic renal failure hospitalized at the University Hospital of Poitiers (CHU de Poitiers) and presenting a CRBSI.
Exclusion: pregnant or breeding women, pneumonia, septic shock (which may affect pharmacokinetic parameters and therefore not represent the principal hemodialysis population); CPK >3ULN; known hypersensitivity to Daptomycin.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetics of Daptomycin at 10 mg/kg after dialysisin conventional hemodialysis in patients with central catheter related infections. Timepoint: 1 week. Method of measurement: Cmax, Cmin, AUC.
- Secondary Outcome Measures
Name Time Method To evaluate clinical parameters (physical examination, vital signs and temperature) in order to monitor infection evolution and side effects in relation to Daptomycin treatment. Timepoint: 2 weeks. Method of measurement: Cinical examination.