None, explorative study: explore whether the current dosing regimen of ciprofloxacin, recommended by the SWAB guidelines and applied at the Academic Medical Center for patients with various degrees of renal function admitted at general wards,…
ID
Bron
Aandoening
Infections treated with ciprofloxacin, according to standard of care
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To investigate whether the current dosing regimen of ciprofloxacin, recommended by the SWAB guidelines and applied at the Academic Medical Center for patients with various degrees of renal function admitted at general wards, results in the target PK/PD index of AUC0-24/MIC ≥ 125.
Achtergrond van het onderzoek
The target pharmacokinetic/pharmacodynamic (PK/PD) index of the antibiotic ciprofloxacin is the Area Under the plasma concentration-time Curve (AUC) over the minimum inhibitory concentration (MIC), with target AUC in 24 hours (AUC0-24) / MIC values greater than 125. With this study, we aim to investigate whether the current dosing regimen of ciprofloxacin, recommended by the Dutch �Stichting Werkgroep Antibioticabeleid� (SWAB) and applied at the Academic Medical Center for patients with various degrees of renal function admitted at general wards, results in the target PK/PD index of AUC0-24/MIC ≥ 125.
Doel van het onderzoek
None, explorative study: explore whether the current dosing regimen of ciprofloxacin, recommended by the SWAB guidelines and applied at the Academic Medical Center for patients with various degrees of renal function admitted at general wards, results in the target PK/PD index of AUC0-24/MIC ¡Ý 125.
Onderzoeksopzet
For this observational study, three blood samples will be obtained from patients treated with ciprofloxacin according to standard of care, within the first 48hours of treatment.
Onderzoeksproduct en/of interventie
none.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Receiving ciprofloxacin therapy intravenous (iv) or per os (po) as part of standard care
- Age ¡Ý 18 years
- Admitted to general ward of the AMC
- Informed consent is obtained
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Incapacitated patients, i.e. a minor or legally incompetent adult
- Treatment with ciprofloxacin is started elsewhere
- Hemodialysis or peritoneal dialysis during treatment with ciprofloxacin
- Ciprofloxacin administered as prophylactic treatment and not as a treatment of a (suspected) infection
- Patients admitted to the intensive care unit (ICU)
- Severely burned patients, defined as a burned surface ¡Ý 10%
- Persons who cannot speak and read the English or Dutch language
- Informed consent is not obtained
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6653 |
| NTR-old | NTR6887 |
| CCMO | NL63263.018.17 |
| OMON | NL-OMON44298 |