All patients receiving ciprofloxacin prophylaxis as standard care will be included, regardless of treatment with different cytostatic agents, regardless of the severity of adverse effects of the treatment (in particular mucositis) and regardless of the degree and duration of neutropenia, as long as ciprofloxacin is recommended as infection prophylaxis within the applied treatment protocol.
Conditions
Interventions
No intervention in patient’s ‘treatment’ is made, intervention consists of four venapunctures in a time period of 48 hours, obtaining a maximum of 12 ml of blood in total and one questionnaire about t
Sponsors
Amsterdam UMC - location Academic Medical Centre (AMC), University of Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: Hospitalized adult patients (age = 18 years) receiving ciprofloxacin as infection prophylaxis as part of standard care prescribed by the treating physician.
Exclusion criteria
Exclusion criteria: Four patient-groups will be excluded as they are known to exhibit altered pharmacokinetics of antibiotics: patients in the intensive care unit (ICU), all patients receiving renal replacement therapy (RRT), patients with cystic fibrosis (CF) and severely burned patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-24/MIC= 125, in which all relevant commensal Gram-negative bacteria of the intestinal tract will be taken into account. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax/MIC = 8, and fAUC0-24/MIC = 90 based on an average unbound fraction of ciprofloxacin of 70% and analyze the frequency of positive cultures with ciprofloxacin-resistant organisms or ESBL-producing Gram-negative bacteria in patients treated for haematological malignancies. | — |
Contacts
Public ContactSuzanne L. de Vroom
Amsterdam UMC, location Academic Medical Centre (AMC), University of Amsterdam
Outcome results
None listed