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ID
Source
Brief title
Health condition
infections
kinetics
infusion
flucloxacillin
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part A: (step 1) A quantitative description of the pharmacokinetics flucloxacillin in non-critically ill patients: changes in (unbound) flucloxacillin level-time profiles and the possible relationship with renal function and demographics. Step 2: A dosing regime for continuous administration of flucloxacillin in which 90% of the population exceeds 100% fT>MIC. Part B: The percentage of patients exceeding the PK target of 100% fT>MIC with the new dosing regime.
Secondary outcome
Part B: A description of the tolerability of the new continuous dosing scheme.
Background summary
waiting for MEC approval
Study objective
The small spectrum antibiotic flucloxacillin is approved in an intermittent dosing regime. The antibacterial activity of flucloxacillin is time dependent so continuous infusion is probably more effective. Furthermore, for some patients continuous dosing can have practical benefits. As it stands, the optimal flucloxacillin dosage for continuous infusion is unknown. Studies indicate that a lower dosage of continuous infusion might be sufficient.
Study design
after finishing flucloxacillin therapy
Intervention
Part A: none
Part B: altered dosage flucloxacillin
Sarah Wilkes
Deventer 7416 SE
The Netherlands
T: (0570) 53 6242
E: s.wilkes@dz.nl
Sarah Wilkes
Deventer 7416 SE
The Netherlands
T: (0570) 53 6242
E: s.wilkes@dz.nl
Inclusion criteria
- The patient is at least 18 years of age
- The patient has started with intravenous flucloxacillin as indicated by their physician
Part B
The patient is at least 18 years of age
- The patient has an indication for the treatment of flucloxacillin with continuous infusion as indicated by their physician
Exclusion criteria
The patient who is admitted to the intensive care unit
- Pregnant women
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5578 |
| NTR-old | NTR5934 |
| Other | METC Zwolle/Isala : 16.06103 dz |