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…
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AUC0-24/MIC
Secondary outcome
Cmax/MIC
fAUC0-24/MIC
Clinical response: days of fever, decrease (%) in CRP and leucocyte count,
length of hospital stay and need for switching ciprofloxacin to a more
broad-spectrum antibiotic.
Background summary
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. Only sparse data is available
demonstrating that this target is reached when patients are treated with
conventional dosing regimens. The small number of studies published on this
subject show that for critically ill patients as well as for patients admitted
at general wards, the ciprofloxacin efficacy target of AUC0-24/MIC * 125 is
often not reached. Moreover, there are no prospective data that show that the
recommended dose reduction of ciprofloxacin in patients with renal impairment
results in achieving the target PK/PD index.
Study objective
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.
Study design
Observational, prospective single centre, cohort study.
Study burden and risks
Risks imposed by participation are considered negligible. Participation itself
does not bring any benefit, but the group related benefit could be significant.
With the results of this study, current recommended ciprofloxacin dosing
regimens are justified or an advice to reconsider current guidelines will be
obtained.
Meibergdreef 9
Amsterdam Zuid-Oost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuid-Oost 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Receiving ciprofloxacin therapy as part of standard care for a (suspected) bacterial infection; urinary tract infection, pneumonia, wound infection, sepsis, abdominal infection or other infection.
Age * 18 years and admitted to a general ward of the AMC.
Exclusion criteria
Incapacitated patients.
Treatment with ciprofloxacin is started elsewhere.
Hemodialysis or peritoneal dialysis during treatment with ciprofloxacin.
Ciprofloxacin given 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63263.018.17 |
| OMON | NL-OMON25299 |