| Trial ID: | L1627 |
| Source ID: | NCT02285075
|
| Associated Drug: |
Temocillin Pk/Pd In Haemodialysis
|
| Title: |
Temocillin Pharmacokinetic in Hemodialysis
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Gram-Negative Bacterial Infections|Renal Failure Chronic Requiring Hemodialysis
|
| Interventions: |
DRUG: temocillin PK/PD in haemodialysis
|
| Outcome Measures: |
Primary: % of the dosing interval time above an MIC of 8 and 16 mg/L (% T>MIC 8 or 16 mg/L), Is T \> MIC 8 and 16 mg/ML \> 40 or 60 %, two to ten days | Secondary: Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, Vd (volume of distribution), two to ten days|Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, T1/2 (serum half life, on and of dialysis), two to ten days|Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, Temocillin clearance (renal and non-renal), two to ten days|Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, Temocillin reduction rate, two to ten days|Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, temocillin removal rate, two to ten days|Determine basic pharmacokinetic parameters of temocillin in intermittent haemodialysis, temocillin protein binding, two to ten days
|
| Sponsor/Collaborators: |
Sponsor: AZ Sint-Jan AV | Collaborators: Paul Tulkens, Louvain drug research institute, belgium|Francoise Van Bambeke, Louvain drug research institute, belgium|Ana Miranda Bastos, Louvain drug research institute, belgium
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
16
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-06
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-01-05
|
| Locations: |
AZ Sint-Jan Brugge Oostende AV, Brugge, 8000, Belgium|Louvain Drug Research Institute (LDRI), Brussels, 1020, Belgium
|
| URL: |
https://clinicaltrials.gov/show/NCT02285075
|
