Infections treated with ciprofloxacin, according to standard of care
Conditions
Interventions
none.
Sponsors
Academic Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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 the peak concentration (Cmax) over the minimum inhibitory concentration (MIC) ≥ 8. 2. 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 for the ciprofloxacin unbound ciprofloxacin concentration of fAUC0-24/MIC ≥ 90. 3. If a large proportion, defined as a percentage of 25% or a minimum of 10 patients does not reach the PK/PD target of AUC0-24/MIC ≥ 125, our secondary aim is to determine whether an AUC0-24/MIC < 125 affects the patients� clinical outcome relative to patients who did reach the target in terms of: - Days of fever, defined as a temperature ≥ 38.5�C, after start of treatment with ciprofloxacin, iv or po - The percentage decrease of leucocyte count and CRP before and after 48-72 hours of treatment with ciprofloxacin - Length of hospital stay in days after start of treatment with ciprofloxacin - Switching ciprofloxacin to a more broad-spectrum antibiotic within 48 hours after start of treatment with ciprofloxacin | — |
Contacts
Public ContactN.G.L. Jager
P.O. Box 22660
Outcome results
None listed