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Defining the optimal dose for continuous flucloxacillin infusion


- candidate number24470
- NTR NumberNTR5934
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jun-2016
- Secondary IDs16.06103 dz METC Zwolle/Isala
- Public TitleDefining the optimal dose for continuous flucloxacillin infusion
- Scientific TitleDefining the optimal dose for continuous infusion using pharmacokinetic modelling
- ACRONYMFlucon study
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedInfection, Antibiotics
- 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 criteriaThe patient who is admitted to the intensive care unit
- Pregnant women
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate1-sep-2021
- Target number of participants30
- InterventionsPart A: none
Part B: altered dosage flucloxacillin
- Primary outcomePart 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 outcomePart B: A description of the tolerability of the new continuous dosing scheme.
- Timepointsafter finishing flucloxacillin therapy
- Trial web sitenone
- statusplanned
- CONTACT FOR PUBLIC QUERIES Sarah Wilkes
- CONTACT for SCIENTIFIC QUERIES Sarah Wilkes
- Sponsor/Initiator Deventer Ziekenhuis
- Funding
(Source(s) of Monetary or Material Support)
Deventer Ziekenhuis
- Publicationsnone
- Brief summarywaiting for MEC approval
- Main changes (audit trail)
- RECORD10-jun-2016 - 8-aug-2016


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