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Target attainment of ciprofloxacin in patients admitted to a general ward: a prospective observational study


- candidate number28199
- NTR NumberNTR6887
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-nov-2017
- Secondary IDsNL63263.018.17 METC AMC
- Public TitleTarget attainment of ciprofloxacin in patients admitted to a general ward: a prospective observational study
- Scientific TitleTarget attainment of ciprofloxacin in patients admitted to a general ward: a prospective observational study
- ACRONYM
- hypothesisNone, 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 125.
- Healt Condition(s) or Problem(s) studiedInfection, Ciprofloxacin
- Inclusion criteria- Receiving ciprofloxacin therapy intravenous (iv) or per os (po) as part of standard care
- Age 18 years
- Admitted to general ward of the AMC
- Informed consent is obtained
- 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 10%
- Persons who cannot speak and read the English or Dutch language
- Informed consent is not obtained
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 2-jan-2018
- planned closingdate31-mrt-2018
- Target number of participants40
- Interventionsnone.
- Primary outcomeTo 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 outcome1. 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
- Timepoints 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.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES N.G.L. Jager
- CONTACT for SCIENTIFIC QUERIES N.G.L. Jager
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD14-nov-2017 - 28-dec-2017


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